Shannon KLINGMAN : Deodorant ~ all-natural ingredients,
us2016151257

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[rexresearch.com](http://rexresearch.com/)**


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**Shannon KLINGMAN**  
**Lume Deodorant**


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[**https://hippocratichustle.com/the-creation-of-lume-deodorant-shannon-klingman-md/**](https://hippocratichustle.com/the-creation-of-lume-deodorant-shannon-klingman-md/)

**The Creation of Lume Deodorant: Shannon
Klingman, MD**

  
 Shannon Klingman, MD is a gynecologist and she realizes
the importance of empowering women to discretely address odor
concerns. In todayas episode, we hear how Dr. Klingman was
tired of the narrative of avaginal odora that has been told
since the beginning of time. She also discusses with us how
there is an industry of products currently on the market that
misleads women into believing that all vaginas have a foul
odor as if it is an inevitable reality for women. Odor. It
happens. But now there is a product that can fight it.  
  
In todayas episode, we will explore how Shannon Klingman, MD,
an OB-GYN from Minnetonka, Minnesota, came up with a new
product that all women have been asking for. A deodorant for
ALL of your parts. And I mean ALL of them. She invented,
produces, markets and distributes Lume Deodorant.   
  


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[**https://lumedeodorant.com/**](https://lumedeodorant.com/)**Ingredients:**Water, Mandelic Acid, Arrowroot Powder, Tapioca Starch,
Isoamyl Laurate, Sodium Acrylate/ Acryloyldimethyltaurate/
Dimethylacrylamide Crosspolymer, Caffeine, Caprylic/Capric
Triglyceride, Cetyl Alcohol, Isohexadecane, Glyceryl Stearate,
PEG-100 Stearate, Sodium Lactate, Panthenol, Allantoin,
Xanthan Gum, Sclerotium Gum, Tocopherol, Polysorbate 60,
Lecithin, Pullulan, Aloe Barbadensis Leaf Juice,
Ethylhexyglycerin, Phenoxyethanol, Tetrasodium Glutamate
Diacetate, Silica, Fragrance\*  
  
\*Lavender Sage is scented with only pure essential oils, while
our other dynamic scents also contain naturally derived, skin
safe botanicals. All of our ingredients are phthalate free and
we entrust Berje with all of our aromatic sourcing. Our
unscented products do not contain any essential oils or added
fragrance.

  


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**US2016151257**  
**PRODUCTS AND METHODS FOR REDUCING MALODOR FROM THE PUDENDUM   
[ [PDF](US2016151257.pdf) ]**

  
**CLAIM TO PRIORITY**  
  
[0001] This application claims priority to U.S. patent application
Ser. No. 14/613,420, aProducts and Methods for Reducing Malodor
from the Pudendum,a filed Feb. 4, 2015 by Shannon Klingman, which
claims priority to U.S. patent application Ser. No. 12/875,123,
aProducts and Methods for Reducing Malodor from the Pudendum,a
filed Sep. 2, 2010 by Shannon Klingman, which in turn claims
priority to both U.S. Patent Appl. Ser. No. 61/309,831, aProducts
and Methods for Reducing Malodor from the Pudendum,a filed Mar. 2,
2010 by Shannon Klingman, and U.S. Patent Appl. Ser. No.
61/289,992, aProducts and Methods for Reducing Malodor from the
Pudendum,a filed Dec. 23, 2009 by Shannon Klingman; and also
claims priority to U.S. patent application Ser. No. 14/604,733,
aAntiperspirants and Deodorants,a filed Jan. 25, 2015, which in
turn claims priority to U.S. patent application Ser. No.
12/823,834, aAntiperspirants and Deodorants,a filed Jun. 25, 2010,
which claims priority to U.S. Patent Appl. Ser. No. 61/325,317,
aImproved Antiperspirant,a filed Apr. 17, 2010; all of which are
hereby incorporated by reference in their entireties for all
purposes.  
  
**BACKGROUND**  
**[0002] 1. Field of the Invention**  
  
[0003] This invention pertains to products and methods for
personal care and odor control, particularly for reducing or
preventing unwanted odor from the pudendum.  
  
**[0004] 2. Description of Related Art**  
  
[0005] Fishy odors from the pudendal region or genitalia of the
female body have long been a source of annoyance and embarrassment
to adult and teenaged women. Women seeking help from physicians
are frequently given antibiotics such as metronidazole, based on
the long-standing belief that vaginal bacteria are the cause of
the problem. Indeed, a fishy odor is commonly considered to be a
symptom for bacterial vaginosis (see, for example, aBacterial
Vaginosis,a Wikipedia,
http://en.wikipedia.org/wiki/Bacterial\_vaginosis, accessed Nov.
17, 2009). Others seeking relief have tried a variety of products
such as douches which may provide only short-term decrease in the
odor (if the vagina was the actual source of the odor). In spite
of many medications and feminine hygiene products, there has been
a long-standing unmet need in this area, fueled by lack of
understanding about the causes and the nature of the problem,
especially the assumption that fishy odor only arises from the
vagina due to bacterial imbalance or infectious cause such as
bacterial vaginosis and trichomonas.  
  
[0006] The aWhiff testa for vaginosis involves treating body
fluids with potassium hydroxide (KOH). A resulting fishy odor
produced by an amine reaction is taken as an indicator for the
presence of anaerobic bacteria. However, the amine reaction or
related reactions that result in a fishy odor can take place
without addition of KOH, but under other elevated pH conditions on
the pudendum. The materials serving as a source for the
nitrogen-containing compounds released as fishy odor (e.g.,
trimethylamine) can include semen, blood, urine, cervical mucus
and post menopausal physiologic discharge. When these are brought
in contact with the anaerobic bacteria from the rectum, an
unpleasant fishy odor will result. The odor is known to be
associated with reactions from bacteria, but the historic focus on
bacteria in the vagina and the assumption that vaginitis or more
specifically, bacterial vaginosis, is the cause of the odor may
have misled many in seeking for solutions that treat bacteria in
the vagina.  
  
[0007] We have found that for many women, the source of the odor
is more commonly from the pudendum (including the intergluteal
folds and external genitalia), where anaerobic bacteria from the
lower gastrointestinal (GI) tract or other sources can be found.
These anaerobic bacteria may be especially present on the external
skin around the perianal anatomy.  
  
[0008] The new recognition that vaginal bacteria are not cause of
fishy odor in many women is of special significance, and helps
explain why antibiotic treatments and other standard treatments
have fared so poorly in treating many cases of fishy odor, and why
may women presenting symptoms of fishy odor do not actually have
bacterial vaginosis when thorough testing is conducted (see, for
example, N. K. Lowe et al., aAccuracy of the Clinical Diagnosis of
Vaginitis Compared With a DNA Probe Laboratory Standard,a
Obstetrics & Gynecology, vol. 113, no. 1, January 2009, pp
89-95, abstract available online at
http://journals.lww.com/greenjournal/Abstract/2009/01000/Accuracy\_of\_the\_Clinical\_Diagnosis\_of\_Vaginitis.15.aspx
and Hope K. Haefner, aConquering Resistant Vulvovaginitis,a 2007,
presentation available online at
http://www.yellowdocuments.com/12180308-advancements-in-benign-vulvar-and).
It also points to the long unmet need for improved means of
reducing or preventing fishy odor by better controlling the
activity of anaerobic bacteria on the pudendum, particularly those
interacting with or feeding on nitrogen compounds in body fluids
such as semen, blood, urine, and feces.  
  
[0009] It is believed that a particularly significant discovery is
the recognition that the source of a fishy odor for many women is
not bacteria in the vagina, nor bacteria coming from the vagina,
but anaerobic bacteria from non-vaginal sources such as the
gastrointestinal tract. An understanding of this discovery can be
enhanced in part by consideration of a rare metabolic disorder,
trimethylaminuria, a disorder occurring when humans have an
impaired version of the enzyme flavin-containing monooxygenase 3
(FMO3), which converts trimethylamine to trimethylamine N-oxide
during the metabolism of some nitrogen-containing compounds such
as choline or phosphocholine. With impaired FMO3 activity,
trimethylamine concentrations become elevated and strong fishy
odor can be generated by the sweat and other body fluids of a
person, making life difficult and painful. Foods rich in choline
are especially problematic for those with trimethylaminuria, since
it leads to production of large amounts of trimethylamine. Without
wishing to be bound by theory, it is believed that the release of
trimethyl amine and possibly other nitrogenous compounds produced
by anaerobic bacteria at elevated pH on the pudendum of the human
body is analogous to the production of trimethylamine in the body
when oxidizing enzymes are impaired in those suffering from
trimethylaminuria. Again, without wishing to be bound by theory,
recognition of this analogous condition in light of the newly
recognized mechanisms for fishy odor generation on the skin of the
pudendum also suggests that semen may be an especially important
component in the production of fishy odor in some cases, for
semen, of all body fluids, may be the richest in choline and is
among the richest natural sources of choline and water-soluble
choline compounds, and thus is believed to be a highly significant
potential source for trimethylamine production by certain
anaerobic bacteria on the pudendum.  
  
[0010] Thus, we have discovered that the introduction of semen,
blood, urine, feces, and other body fluids into the pudendum,
including the perineum and adjacent regions, can raise the pH on
the skin and provide the nitrogenous materials and alkaline
conditions for bacterial-assisted production of significant
amounts of volatile amine compounds such as trimethylamine, giving
rise to a fishy odor. While the reactions involved may be similar
to those that occur from bacterial vaginosis, fishy odor can be
produced on the pudendum under benign conditions. In other words,
the vagina is not the key factor when trying to solve the problem
of transient fishy odor for most women.  
  
[0011] For effective prevention of the fishy odor from the amine
reaction, wiping or washing alone is inadequate. The pH of the
environment of the perianal bacteria needs to be maintained in an
acidic state such as at a pH less than about 5.5, or less than
about 5.3, or less than about 5.1, in order to hinder the amine
reaction that causes the unwanted fishy odor. 3.5 to 4.2 is the
normal range of the pH of the vagina, and a pH in this range can
be suitable for the pH of the pudendum. Thus, a suitable range for
pH may be, by way of example, from about 3 to about 5.5, from
about 3.2 to about 5, from about 3.5 to 4.5, or from about 3.5 to
5.0. Without wishing to be bound by theory, our work indicates
that the release of the fishy odor can be triggered by an amine
reaction that occurs when the anaerobic bacteria of the pudendum
come into contact with alkaline bodily fluids such as semen,
blood, feces, and other agents such as soap, in essence, giving a
positive Whiff test on the external genitalia. Possible insight
into related mechanisms may be found, again without wishing to be
bound by theory, in the study of Y. Tsuchiya and E. Endo,
aEnzymatic Reduction of Trimethylamine Oxide,a Tohoku Journal of
Agricultural Research, 1952, pp. 127-133, available online at
http://ir.library.tohoku.ac.jp/re/bitstream/10097/29074/1/KJ00000713720.pdf,
which describes how a bacterial enzyme, triamineoxidase, activates
relatively odorless trimethylamine oxide and renders it
susceptible to reduction to the highly malodorous trimethyl amine
by various dehydrogenases. Several potential inhibitors of the
reaction are explored. On page 130 of Tsuchiya and Endo, results
for the reaction rate for trimethylamine production as a function
of pH shows that a pH above 5.5 such as from about 6 to 8 favors
high levels of trimethylamine, whereas a pH of 5.5 or less, or 5.0
or less, favors low levels of trimethylamine.  
  
[0012] An understanding of the importance of maintaining a low pH
in the external environment of the pudendum relative to the issue
of controlling fishy odor appears to be lacking in prior attempts
to deal with fishy odor. For example, some commonly used products
employ baking soda, an alkaline compound, and a recognition of the
role of the environment external to the vagina and its pH appears
to have been lacking in terms of controlling fishy odor.  
  
[0013] The compositions and methods proposed herein for
controlling fishy odor arise in part from the surprising
realization that the real problem in most cases is not bacteria in
the vagina, but conditions arising from an anatomically inevitable
consequence of intercourse, due to semen form intercourse, leaking
urine, and blood from monthly cycles coming in contact with the
perianal bacteria that can inhabit various parts of the pudendum.
The close physical proximity of the vulvar and perianal regions
contributes to the presence of bacteria that can produce or
participate in reactions leading to generation of trimethylamine
or related fishy odor compounds, feeding upon the nitrogenous
compounds coming from intercourse, urine, menstruation, feces,
etc.  
  
[0014] With a realization of the nature of the origin of fishy
odors due to elevated pH and associated conditions in the
pudendum, we were able to subsequently develop what is believed to
be the first product that addresses the real problem (for many
women) over a prolonged period of time.  
  
[0015] Vinegar wipes, douches, and other acidic products have been
proposed for personal cleansing, but such products have generally
been developed for rapid cleansing and not for lasting control of
pH. Thus, even highly acidic vinegar wipes only provide a
short-term change in pH, as the acidic components is applied and
then wiped or washed off or otherwise neutralized or quickly
removed from the skin. With the viscous carrier of many
embodiments disclosed herein, acidifying components can be
available for a prolonged period of time to effectively control
the pH of the environment. Further, with larger molecular weight
alpha-hydroxy acids disclosed herein (for many embodiments) that
do not rapidly penetrate the skin, the alpha-hydroxy acids can
remain on or above the skin to effectively maintain the pH in a
suitable range for a prolonged period of time, unlike much lighter
acids.  
  
[0016] Thus, there is a need for new products and methods that can
address the surprising discoveries regarding the sources of fishy
odor in many women, and that can overcome the long-standing unmet
needs that have not been adequately addressed by previous
products, formulations, and methods.  
  
[0017] Many retail and prescription products have been marketed
are directed at treating bacteria in the vagina, which again do
not address the issue of the external environment in the pudendum.
Most on the retail side are a cover-up with baking soda and
perfumes or other ingredients that do not address the problem or
may even exacerbate it at the true source (albeit the previously
unrecognized source).  
  
[0018] The recognition that the source of the fishy odor is
frequently from the pudendum and not from the vagina helps
explain, in retrospect, why treatments based on attacking bacteria
on the vagina have been relatively ineffective for so many women
for so long, and may also help explain why misdiagnosis of
vaginosis is such a common problem (see aThrowing the Dice for the
Diagnosis of Vaginal Complaints?a by Andreas Schwiertz et al.,
Annals of Clinical Microbiology and Antimicrobials, Vol. 5. No. 4,
2006, available online at
http://www.ann-clinmicrob.com/content/5/1/4). The new
understanding of the need to provide long-term control of pH on
the skin of the pudendum also helps explain, in retrospect, why
previous solutions employing wipes and other means did not provide
lasting or effective solutions. What is needed, then, is an
effective system or method for providing a suitable acidic pH over
a prolonged period of time in the pudendum or portions thereof
such that the amine reactions giving rise to a fishy odor can be
impeded, resulting in a significant decrease in the production of
unpleasant odors.  
  
[0019] In spite of the surprising discovery that a major source
for fishy odor was not from the vagina itself but from the
external skin of the pudendum, particularly when the pH was
elevated by the presence of semen, blood, or other materials or
factors, we found that various efforts to decrease pH were not
necessarily adequate to provide an acceptable solution, for, among
other reasons, there is a risk of skin irritation or other
unwanted responses with prolonged exposure to many acidic
compounds. For effective treatment of the newly appreciated causes
of unwanted fish odor for many women, we have also discovered that
a lasting reduction in fishy odor and associated problems of the
inevitable chronic presence of anaerobic bacteria in the pudendum
require new strategies to provide sustained pH control in ways
that do not irritate the skin. Thus, there is a long-standing need
to provide sustained pH control in non-irritating means to reduce
the common problem of fishy odor production from the pudendum.  
  
[0020] A further challenge involves body odors associated with
perspiration, particularly in the pudendum. Bacteria such as
Corynebacteria feed off materials in the sweat, particularly the
apocrine sweat glands, and produce unpleasant odors. Such glands
tend to be abundant in the groin and pudendal area. Products are
available such as antiperspirants or deodorants to mask odors or
reduce perspiration, but products that may be suitable for
underarm use, for example, may not be safe or effective on the
pudendum. In particular, the metal-containing compounds such as
aluminum salts that are widely used for their ability to reduce
perspiration have been the subject of as-yet unresolved concerns
about their long-term health effects. Safe, effective alternatives
are needed. Given the limitations in currently available products,
there is a need for deodorants and antiperspirants that are
effective in preventing perspiration or associated odor on the
body, particularly on the pudendum, while reducing perceived
health risks associated with aluminum compounds or other harsh
chemicals.  
  
**SUMMARY**  
  
[0021] We have found that relatively non-irritating alpha-hydroxy
acids such as mandelic acid or combinations of mandelic acid and
other alpha-hydroxy acids such as lactic acid, in combination with
a suitable carrier such as a protective lipophilic carrier, a
bioadhesive, or a suitable wipe formulation, can provide
acidifying agents that are effective in controlling the pH in the
pudendum while not irritating the skin. By virtue of the acidic
environment provided by such compositions, the reactions that
produce fishy odor on the pudendum can be controlled such that the
odor is substantially reduced or eliminated. In many embodiments,
the acidifying agents can remain active in the pudendum over a
prolonged period for lasting odor reduction. Such compositions may
be applied to the body in a variety of ways, such as by
application using a pretreated wipe, pad, or absorbent article
containing the acidifying composition that transfers to the body,
or by direct application to the body using a spray or other
dispenser or by application using the fingers or other means to
apply the composition onto the pudendum.  
  
[0022] Further, we have found that personal care compositions
comprising caffeine can provide highly effective protection
against perspiration without the need to use aluminum compounds.
We have also found that personal care compositions comprising
caffeine (a methylxanthine) or related xanthines can be used to
reduce perspiration and/or odor. In several embodiments, the
xanthine compound is combined with alpha-hydroxy acids such as
relatively non-irritating mandelic acid to significantly reduce
body odor in regions of the body such as the underarm region
normally subject to undesirable odors associated with
perspiration. Thus, in one embodiment, we have developed a
personal care composition for reducing at least one of
perspiration and body odor comprising an effective amount of a
xanthine compound and at least 0.5% by weight of a carboxylic acid
in a suitable carrier for application to the skin. In another
aspect, we have developed an antiperspirant for use on human skin
comprising about 1% by weight or greater of a xanthine compound in
a suitable carrier. In yet another aspect, we have developed an
effective antiperspirant composition comprising at least 1%
caffeine, at least 1% mandelic acid, at least 5% starch, and
substantially no aluminum or zirconium compounds. Further, we have
developed a method of making a substantially aluminum-free
personal care composition comprising blending caffeine, an
alpha-hydroxy acid, and a suitable carrier to form a viscous
composition, and packing the composition in a container with
indicia associated therewith instructing a user to apply the
composition to the underarms region or other region of the body
likely to experience body odor associated with sweat.  
  
[0023] In another aspect of the invention, we have developed a
method for reducing malodor from the pudendum, comprising: (a)
providing a user with a product comprising an acidifying
composition having from 0.5% to 10% by weight of mandelic acid or
salts thereof and from 0.5% to 10% by weight of caffeine or salts
thereof, said acidifying composition having a pH between 2.8 and 5
and provided in a viscous carrier suitable for application to the
skin, and (b) providing directions to the user to apply the
acidifying composition to the pudendum. Alternatively, the upper
limit for the caffeine or salts thereof may be 8.3% by weight,
which corresponds to a mass ratio of the carboxylic acid (mandelic
acid) to total xanthine (here caffeine or salts thereof) of 1.2
when the carboxylic acid is mandelic acid at an upper limit of 10%
by weight. Other possibilities for the mass ratio of carboxylic
acid to xanthine compounds are discussed hereafter.  
  
[0024] In another aspect of the invention, a method is provided
for reducing odor from the pudendum a user, comprising: (a)
preparing a personal care composition for reducing body odor
comprising from 0.5% to 8.3% by weight of a methylxanthine or
salts thereof and from 0.5% to 10% by weight of mandelic acid,
wherein the personal care composition is in the form of a viscous
compound selected from a cream, a lotion, a paste, or a slurry,
the personal care composition comprising less than 0.5% by weight
of zirconium and aluminum antiperspirant compounds; and (b)
providing the personal care composition in packaging with indicia
instructing the user to apply the personal care composition to the
pudendum in order to reduce at least one of malodor and
perspiration.  
  
[0025] In yet another aspect of the invention, a method is
provided for reducing or preventing malodor from the pudendum,
comprising: (a) providing a user with a product comprising an
acidifying composition having at least about 0.5% by weight of
mandelic acid, at least 0.5% by weight of caffeine or salts
thereof, said acidifying composition having a pH between about 2.8
and 5 and being substantially free of trimethylamine, and (b)
providing directions to the user to apply the acidifying
composition to the pudendum.  
  
[0026] The discovery that a xanthine compound such as caffeine can
be effective in reducing malodor from perspiration at the
concentration claimed herein is surprising, for caffeine is known
to increase perspiration and is said to increase body odor when
consumed (see, for example,
http://www.health911.com/remedies/rem\_bodyo.htm, accessed May 28,
2010,
http://ezinearticles.com/?How-to-Stop-Heavy-Perspiration&id=608249
and http://www.dryidea.com/dryidea/index.cfm?page\_id=7 under the
heading, aMYTH: When I Eat Garlic, My Sweat Smells Like Garlic,a
both accessed Mar. 30, 2010). Given its apparent role in
increasing perspiration and body odor, the discovery that caffeine
can, when properly applied to the body, actually serve to reduce
body odor and/or to reduce perspiration is counterintuitive. The
synergy between caffeine and related compounds with carboxylic
acids such as mandelic acid in reducing body odor from
perspiration is also highly surprising relative to the state of
understanding before the advances described herein. However, upon
discovery of these surprising effects, a theory for the surprising
efficacy can be proposed with hindsight by consideration of the
ability of caffeine to restrict blood vessels in the skin.  
  
[0027] Without wishing to be bound by theory, we propose that a
vaso-restrictive function of caffeine when topically applied helps
to close pores rather than plugging them (as in certain prior
antiperspirant products) with the reaction products of metal
complexes with biological matter. The closing of sweat-releasing
pores through the action of caffeine is believed to help reduce
the flow of sweat from sweat glands, thus providing an
antiperspirant function. Alternatively or in addition, the
caffeine can act to reduce blood flow to the surface of the skin,
and it is possible that the reduced blood flow works to reduce
sweat production from sweat glands. Alternatively, mechanisms that
reduce blood flow may also work to reduce the supply of
perspiration available in or deliverable by sweat glands via
similar mechanisms.  
  
[0028] Caffeine and other vasoconstrictors or chemically related
compounds may be used in the personal care compositions of the
present invention, including xanthine derivatives. Caffeine is a
methylxanthine (a derivative of xanthine having a methyl group).
Xanthine (3,7-dihydro-purine-2,6-dione), is a purine base found in
most human body tissues and fluids and in other organisms.  
  
[0029] In forming a personal care composition, the caffeine or
other xanthines may be provided as a solute in an aqueous
solution, a non-aqueous solution in combination with an alcohol or
other liquid, an emulsion, a mixture of encapsulated ingredients
such as microencapsulated caffeine in combination with ingredients
in one or more phases, or in other suitable forms. Emulsions, if
used, can be oil in water emulsions or water in oil emulsions, for
example. Water-in-water emulsions, such as gel particles in an
aqueous phase, may also be considered, with the xanthine
distributed in either or both phases. The caffeine or other
xanthines may also be provided in solid form, such as in the form
of a powder. Either solid or solute forms of one or mores
xanthines may be encapsulated. For example, microcapsules of
caffeine may be prepared with capsule walls that are at least one
of (a) water-soluble, (b) fusible (e.g., melting above a
predetermined temperature such as at about 95A deg F. or higher), or
(c) frangible (such that they can break in response to friction to
release the contained ingredients).  
  
[0030] Other xanthines are also believed or known to have
vasoconstrictive effects relative to the skin or other potentially
useful effects relative to antiperspirant and deodorant products,
including pharmacological effects related to those of caffeine,
and thus xanthines such as methylxanthines and derivatives thereof
are considered within the scope of certain embodiments of the
present invention. Methylxanthines include theophylline
(1,3-dimethyl-7H-purine-2,6-dione, also known as
dimethylxanthine), caffeine
(1,3,7-trimethyl-1H-purine-2,6(3H,7H)-dione, also known as
1,3,7-trimethylxanthine or methyltheobromine), and theobromine
(3,7-dimethyl-2,3,6,7-tetrahydro-1H-purine-2,6-dione, also known
as 3,7-dimethylxanthine or xantheose). Derivatives of xanthine
compounds including salts thereof may be used, including caffeine
citrate and other salts with carboxylic acids.  
  
[0031] In some embodiments, the caffeine or other xanthine
compound may be present at any effective concentration such as
about 10% by weight or higher, about 5% by weight or higher, about
2% by weight or higher, about 1% by weight or higher, or about
0.5% or higher. For a carboxylic acid such as mandelic acid or a
mixture of alpha-hydroxy acids, it may be present at any effective
concentration such as about 10% by weight or higher, about 5% by
weight or higher, about 2% by weight or higher, or about 1% by
weight or higher, or about 0.5% or higher. The mass ratio of
carboxylic acid to total xanthine compounds may be substantially
zero or any practical finite number such as from about 0.1 to
about 5.0, from about 0.1 to about 1, from about 0.1 to about 0.5,
or from about 1 to about 5, or substantially greater than 1 such
as about 1.2 or greater.  
  
[0032] The discovery of the surprising efficacy of such
formulations stemmed from surprising discoveries regarding the
role of mandelic acid and related carboxylic acids in suppressing
odor generation on the body, and from other experimental
discoveries regarding the surprising benefits of topically applied
caffeine in reducing underarm odor, alone or in combination with
alpha-hydroxy carboxylic acids.  
  
[0033] The xanthine compound and carboxylic acid in many
embodiments are combined with a carrier that may be a liquid such
as an aqueous solution, a wet wipe formulation with alcohol or
substantially alcohol free, or a viscous carrier having
substantially greater viscosity than water. The viscous carrier
may be a lipophilic carrier such as a mineral oil, a gel, a cream,
an emulsion, a bioadhesive, and the like.  
  
[0034] The xanthine compound and a suitable carboxylic acid may be
combined with additional ingredients such as organic oils,
silicone compounds, cyclomethicone, water, various polymers that
control viscosity, film formation, or other mechanical or fluid
properties, fragrances, coloring agents, encapsulated compounds,
solvents, propellants, surfactants, and the like. For example, an
antiperspirant may comprise caffeine or related compounds in a
base made with a starch with bonding agents such as a wax or oil.
In another embodiment, the antiperspirant may comprise active
ingredients such as caffeine and an acidifying agent such as a
carboxylic acid combined with a silicone wax, cyclomethicone, and
a fatty alcohol according to the carrier materials discussed in
U.S. Pat. No. 5,888,486.  
  
[0035] As used herein, apudenduma refers to the external genitalia
and surrounding regions, including the interlabial folds, the
clitoral region, the perineum, the perianal region, the vulvar and
perivulvar regions, and the intergluteal folds.  
  
[0036] As used herein, adeodorantsa and aantiperspirantsa both
refer to compositions that are effective in directly or indirectly
reducing unwanted body odors associated with perspiration and/or
bacteria on the surface of the skin. aDeodorantsa may reduce odor
through a variety of means, and such means in the various
embodiments of the present invention may include suppression of
bacterial activity, antimicrobial mechanisms, chemical
interference with odor generation mechanisms, removal or
modification of feedstuff for odor-producing bacteria, and the
like. aAntiperspirantsa generally work to reduce the production of
perspiration, and may do so, for example, by decreasing the size
of pores associated with sweat glands, blocking sweat glands,
reducing the flow of blood or other fluids to sweat glands, and
the like. A deodorant may function as an antiperspirant but need
not do so to be a deodorant. The compositions of various
embodiments of the present invention may generally be described as
deodorants and in many cases may generally be described as
antiperspirants, though a composition that has limited
antiperspirant efficacy is not necessarily outside the scope of
the claimed invention, which is defined by the claims appended
hereafter.  
  
[0037] As used in the description, and in the claims, the term
aalpha-hydroxy acida refers to compounds represented by the
following generic structure:  
  
(R1)(R2))C(OH)COOH  
  
where R1 and R2 are H, alkyl, aralkyl or aryl groups. In addition,
R1 and R2 may carry OH, CHO, COOH and alkoxy groups. Typical
alkyl, aralkyl and aryl groups for R1 and R2 include methyl,
ethyl, propyl, isopropyl, butyl, pentyl, octyl, lauryl, stearyl,
benzyl and phenyl etc. The alpha-hydroxy acids include, but are
not limited to, lactic acid, mandelic acid, glycolic acid, malic
acid, 2-hydroxyoctanoic acid, 2-hydroxydecanoic acid, and citric
acid. In some embodiments, the alpha-hydroxy acid has 13 or fewer
carbons, 12 or fewer carbons, 11 or fewer carbons, 10 or fewer
carbons, 9 or fewer carbons, or 8 or fewer carbons, such as
between 2 and 14 carbons, between 2 and 11 carbons, between 3 and
11 carbons, between 3 and 13 carbons, between 7 and 12 carbons, or
between 8 and 12 carbons.  
  
[0038] To provide an effective quantity of a suitable
alpha-hydroxy acid in the environment on the pudendum, a viscous
carrier substantially more viscous than water can be effective in
retaining the material. As used herein, a material such as a
liquid is said to be aviscousa when it has a viscosity of from
about 6 mPaA*s (millipascal-seconds) to about 300,000 mPaA*s when
measured at 25A deg C., more specifically from 15 mPaA*s to 150,000
mPaA*s, and more specifically still from 50 mPaA*s to 150,000 mPaA*s.
Viscosity herein is measured on neat composition using a
Brookfield RVT, T-C Spindle at 5 rpms and Heliopath Stand, as
described in US Pat. Application 20060002876, aPersonal Care
Compositions with Improved Hyposensitivity,a published Jan. 5,
2006 by C. M. Cahen, herein incorporated by reference to the
extent that it is noncontradictory herewith. In general, a viscous
composition typically provides improved application
characteristics when compared with products having a viscosity
similar to that of water when applied directly by the user using
manual (i.e. hand) application.  
  
[0039] A lipophilic viscous carrier such as a cream can further
protect the skin and reduce risks of irritation from the
alpha-hydroxy acid. One or more suitable alpha-hydroxy acids in
combination with a viscous lipophilic carrier can be applied to
the pudendum using the fingers or via a wipe or pad, or can be
transferred from another article such as the pretreated surface of
an absorbent feminine pad such as a pantiliner. In typical
embodiments, the composition is only applied to the pudendum or
other external skin and is not applied to the vagina. Indeed,
indicia or other information associated with compositions within
the scope of the present invention may direct the user to not
apply the composition within the vagina, and may further indicate
that the formulation is intended for application only to the
pudendum if prevention or reduction of fishy odor is desired, or
for improved health of the pudendal region.  
  
[0040] Thus, in one aspect, a product is disclosed for application
to the pudendum of a user to reduce fishy odor, the product
comprising about 0.5% by weight or greater mandelic acid and 0.5%
by weight or greater of a xanthine compound or salt thereof in a
viscous lipophilic carrier, the product being physically
associated with indicia specifying that the product should be
applied to the pudendum. As used herein, aphysically associated
witha refers to indicia on an item physically proximate to the
product to enable a user to obtain the information or directions
given by the indicia, and more specifically refers to indicia such
as printed instructions located on a container that contains the
products or on a label or other printed surface connected to a
container of the product or its associated packaging. Examples can
include instructions disposed on or near a dispenser of the
product, a printed card intended to be distributed with the
product and provided near or attached to the packaging, or a label
on a tube or tub that contains the product. Indicia need not be
physically printed with ink but may be displayed in other ways,
including electronic display on electronic paper or other display
means physically associated with the product.  
  
[0041] Compositions within the scope of the present invention may
be provided in the form of pre-treated wipes, including wet wipes
or wipes pretreated with a viscous lotion, or may be applied to a
wipe shortly before contacting the wipe to the pudendum or any
part thereof. In one embodiment, for example, a cream comprising
one or more suitable alpha-hydroxy acids is applied to a wipe,
including a dry wipe or a wet wipe, prior to use. The wipe may be
packaged with the cream already in contact therewith, or may be
packaged with or marketed in association with a quantity of the
cream that can be manually applied to the wipe prior to contacting
the wipe with the pudendum, such that the cream is transferred to
the pudendum. As used herein, a acreama is generally an emulsion
having a kinematic viscosity of greater than 500 centistokes,
typically in the range of 10,000-50,000 centistokes.  
  
[0042] The carrier need not be lipophilic and may, for example,
comprise an aqueous gel or other aqueous bioadhesive comprise a
hydrated polymer. Alternatively, a substantially aqueous,
low-viscosity carrier may be used similar to traditional
water-based wet wipe formulations, but comprising a suitable
alpha-hydroxy acid. For the alpha-hydroxy acid to remain effective
on the pudendum for a prolonged period of time after application
with a wet wipe-style product, additional measures may be taken
such as encapsulation of at least a portion of a quantity of an
alpha-hydroxy acid for sustained release thereof, or providing of
delivery means for sustained contact of a low-pH solution with a
portion of the pudendum.  
  
[0043] In some versions, the with one or more suitable
alpha-hydroxy acids is provided in a container or with a kit that
contains or is physically associated with indicia instructing the
user that the composition is to be applied to the pudendum. The
indicia may indicate that the composition should only be applied
to pudendum or more generally that it is intended for use on the
pudendum or should be applied on the pudendum. The indicia may
further specify suggested methods for repeat application,
including time intervals or conditions which would require more
frequent application. In some versions, the indicia indicate that
the product can help control fishy odor arising from the pudendum,
and may indicate the benefit can be obtained by maintaining a
suitable pH range in the environment on the pudendum.  
  
[0044] In one aspect, a personal care composition is disclosed
which comprises a viscous lipophilic carrier and at least 1% by
weight of an alpha-hydroxy acid having a molecular weight of at
least 125 or at least 140 (the molecular weight of mandelic acid
is about 152), or having at least 1% by weight of mandelic acid or
a derivative thereof. In some versions, the alpha-hydroxy acid may
have a solubility in water of at least 1 gram per 10 ml of water
(mandelic acid has a solubility of 1 gram in 6.3 ml of water) at
25A deg C., and/or may have an acidity expressed as pKa of at least
about 2.0 or at least about 3.0 (larger numbers indicate weaker
acids; mandelic acid has a reported pKa of 3.37 and lactic acid
has a reported pKa of 3.86). The composition may further comprise
at least 0.5% by weight of a xanthine compound such as caffeine,
or salts thereof, and more particularly may have from 0.5% by
weight to 8.3% by weight of a xanthine compound or salts thereof.  
  
[0045] The personal care composition may be provided in a
container provided with indicia instructing users to apply the
composition to the external skin of the pudendum, and may further
specify that so doing will help reduce undesirable odor or the
bacteria that cause such odor, and may further indicate that odor
control can thereby be provided over a prolonged period of time.  
  
[0046] In another aspect, a method is disclosed for reducing
undesirable odors arising from the pudendum of a user, the method
comprising: a) providing a composition comprising at least 0.5% by
weight of mandelic acid or a derivative thereof disposed in a
viscous substantially lipophilic carrier, and b) instructing a
user to apply the composition to the user's pudendum.  
  
[0047] The method may further comprise making a claim that the
composition is effective in reducing fishy odor, and may also
include further instructing the user to repeat application of the
composition to the pudendum after a prolonged period of time has
occurred and/or after exposure to conditions likely to elevate the
pH of the environment of the pudendum, such as intercourse,
contract with blood or feces, or bathing with soap.  
  
[0048] In one aspect, a wipe product is disclosed for reducing the
production of unwanted odor from the pudendum, the product
comprising an openable enclosure containing at least one wipe
pretreated with an acidifying composition, the acidifying
composition comprising mandelic acid and a xanthine, the
acidifying composition having a pH of from about 3.5 to about 4.5
and further comprising at least 50% by weight of a viscous
lipophilic carrier, wherein upon wiping the pudendum with one of
the at least one wipes, the acidifying composition is adapted to
transfer in part to the pudendum and have a substantial portion
thereof remain in contact with the pudendum for a prolonged period
of time after wiping, thereby effectively lowering the pH on the
treated portion of the pudendum for a prolonged period of time.
The acidifying composition may comprise mandelic acid or its
derivatives, and in related embodiments mandelic acid in an
effective amount is present in combination with one more
additional alpha-hydroxy acids such as lactic acid, in a
substantially lipophilic carrier having rheological properties of
a bioadhesive or otherwise have sufficient non-Newtonian
properties (e.g., a relatively high yield stress) such that it
does not readily flow off the body under the influence of gravity
after application to the body. Other alpha-hydroxy acids that may
be considered.  
  
[0049] As used herein, a material with a relatively high yield
stress may be said to anot substantially flow in response to
gravitational forcea or anot readily flow off a surface under the
influence of gravitya if, when applied uniformly to a vertical
surface such as a vertical sheet of clean sodium glass with the
applied layer having a thickness of 2 millimeters over a 2 cmA2 cm
area defining a square with top and bottom sides parallel to the
horizontal plane, the effect of gravity in redistributing the
applied material is relatively minor such that after 30 seconds of
exposure to gravity, the upper half of the square (a 2 cmA1 cm
region of the coated area) still has at least 30% of the
originally applied mass (with no flow at all, it would have 50% of
the originally applied mass). The test should be done at 23A deg C.  
  
[0050] In some embodiments, a first alpha-hydroxy acid such as
mandelic acid and optionally a second alpha-hydroxy acid
composition, such as lactic acid or other acids, are combined with
a xanthine compound to provide a long-lasting acidifying
composition that can control the pH of the pudendum after
application for a prolonged period of time such as at least about
10 minutes, 30 minutes, 60 minutes, 6 hours, 12 hours, or 24
hours. Indeed, in some embodiments, it has been found that a
single treatment with compositions described herein can provide
effective control in preventing fishy odor for periods of 24 hours
or longer.  
  
[0051] In some embodiments, the carrier can be a lipophilic
carrier such as a cream comprising an oil/water emulsion and
having a finite yield stress to allow substantial quantities to
remain in contact with the body after application over a prolonged
period of time. Yield stress may be measured using a static
vane-based test method with the Brookfield YR-1 of Brookfield
Engineering Laboratories (Boston, Mass.). The yield stress at 25A deg
C. may be, for example about 2 kPa s or less, or about 1 kP s or
less, or about 0.2 kPa s or less. Other techniques for providing
sustained presence of acids may be considered in various
embodiments, including the use of time-release encapsulation
technology or barriers that release the actives when triggered by
moisture, pH, activity, or other conditions.  
  
[0052] The carrier can be made from a variety of known agents. It
may comprise a viscous, lipophilic base that is substantially
water free or is a mixture of lipophilic components and an aqueous
solution such as an emulsion. The carrier may also be a
hydrophilic base such as a gel, including bioadhesive gels, or a
solution such as the wetting solution of a wet wipe. The carrier
may also be a foam.  
  
[0053] In one version, a personal care composition for preventing
fishy odor is delivered using a wipe. The wipe may be provided
with the composition already present, such as a wet wipe or
impregnated wipe holding the viscous carrier and active
ingredients (i.e., mandelic acid and a xanthine compound such as
caffeine or salts thereof). Alternatively, the composition may be
provided separately for the user to apply using a wipe or other
substrate such as a tissue. In one version, a single-use pouch or
kit comprises a wipe and a separate dose of the composition that
can be released on to the wipe prior to application.  
  
[0054] Compositions according to selected embodiments of the
present invention may have a pH (as measured, for example, with pH
test trips at 22A deg C.) of about 3.0 to about 5.0, or from about 3.2
to about 4.5, or from about 3.3 to 4.2, such as from about 3.5 to
about 4.2.  
  
[0055] Compositions according to selected embodiments of the
present invention can be provided in a wide variety of forms, such
as gels, creams, foams, impregnated pads or strips, and the like,
many of which can be suitable for prolonged contact against the
human body. Prolonged contact can be achieved direct application
of the active ingredients onto the skin by any known means,
including the use of bioadherents, or by mechanical means in which
an article comprising a composition of the present invention is
held in place against the body by, for example, contact with
underwear or other clothing.  
  
[0056] Some forms of useful products are intended for brief
contact with the human body, such as wet wipes or treated pads
that may make brief contact with the skin of the pudendum to
deliver active ingredients, though in such products, the active
ingredients may be provided in a composition that remains on the
skin to provide protection over a prolonged period of time.
Compositions of selected embodiments of the present invention may
also be provided in forms intended for direct application to the
human body such as rinses, washes, sprays, and the like.  
  
[0057] For embodiments in which a formulation is applied using a
wipe, the wipe can serve not only to deliver the active
ingredients to lower the pH on the body over a prolonged time but
also to mechanically remove debris. Methods of use could include
daily treatment such as after bathing to clean and acidify the
pudendum. The treatment could include use of a prepackaged,
pretreated wipe or of an ordinary wipe that is wetted or coated
with a formulation as described herein.  
  
[0058] In other embodiments, at least one active ingredient may be
in substantially dry or solid form, such as a powder attached to
or disposed within a pad. When wetted by water or aqueous fluids
prior to, during, or after application of the active ingredient to
the body, the active ingredient may at least partially dissolve to
more effectively control the acidity of the environment (e.g.,
that of material on the skin of the pudendum) or to deliver other
benefits.  
  
[0059] In another aspect, a method is disclosed for reducing or
preventing malodor from the pudendum, comprising: (a) providing a
user with a product comprising an acidifying composition having at
least about 0.5% by weight of mandelic acid and 0.5% by weight of
a xanthine compound or salts thereof, said acidifying composition
having a pH between about 3.2 and 4.5, and (b) providing
directions to the user to apply the acidifying composition to the
pudendum. The acidifying composition may further comprise at least
1% by weight of a second carboxylic acid component such as lactic
acid. In some embodiments of the method, the acidifying
composition may have a non-zero yield stress and the directions
for use are adapted to cause the acidifying composition to
effectively remain in contact with the human body for a period of
at least 10 minutes after applying the acidifying composition to
the pudendum according to the directions. The product and the
directions may be adapted such that the composition, when applied
according to the directions, will be effectively kept in contact
with the pudendum for a period of at least 60 minutes, and wherein
the pH on the skin in contact with the composition is between
about 3.5 and 4.5 during a majority of the at least 60 minutes.
Skin pH can be measured with dry pH electrodes, as is known in the
art. See, for example, B. Eberlein-Konig et al., Acta Derm
Venereol. 2000, vol. 80, pp. 188-191, available online at
http://adv.medicaljournals.se/files/pdf/80/3/188-191.pdf.  
  
[0060] The method may further comprise (c) providing one or more
wipes for use with the product, and the step of providing
directions to the user may then include providing directions to
transfer the product from at least one of the one or more wipes to
the pudendum.  
  
**BRIEF DESCRIPTION OF THE DRAWINGS**  
  
**[0061] FIGS. 1A, 1B, and 1C show views of a wipe originally
sealed in a pouch, the wipe comprising a formulation for
reducing malodor.**  
  
**[0062] FIG. 2 shows one version of a container holding multiple
individually sealed wipes for reducing malodor.**  
  
**[0063] FIG. 3 shows a telescopic view of a tub for wipes and
further comprising a container of a cream for application to the
wipes, the cream comprising a formulation for reducing malodor.**  
  
**[0064] FIG. 4 shows a plan view of a wipe with discrete zones
comprising an active ingredient for reducing malodor.**  
  
**[0065] FIGS. 5A and 5B show experimental TMA versus time
profiles for liquid samples containing bacteria and choline with
and without a quantity of added material according to an
embodiment of the present invention.**  
  
**[0066] FIGS. 6A and 6B show experimental TMA versus time
profiles for liquid samples containing bacteria and choline with
and without a quantity of added material according to an
embodiment of the present invention.**  
  
**[0067] FIGS. 7A and 7B show experimental TMA versus time
profiles for liquid samples containing bacteria and choline with
and without a quantity of added material according to an
embodiment of the present invention, further showing the effect
of different concentrations of the added material.**  
  
**DETAILED DESCRIPTION OF THE DRAWINGS**  
  
[0068] FIG. 1A depicts an individual use product 20 containing a
folded wet wipe 24 sealed within a sealed pouch 22, the wipe 24
comprising a personal care composition (not shown) for reducing
malodor in the pudendum. The pouch 22 may be made of a film or
foil wrap or any other suitable flexible materials, and generally
comprises a front side 26, a back side 28, a top end 32, and a
bottom end 34, the top end 32 comprising a tear line 30 which may
be perforated, for example, and a tear-away portion 36 which is
removed by tearing along the tear line 30 to open the pouch 22. Of
course, many alternative means may be used to provide for opening
the pouch 22, including resealable flaps (not shown), tear lines
along any region of the pouch 22, slidable or resealable closures
(not shown) such as those commonly used in sandwich bags, and the
like. In related embodiments not shown here, multiple wipes may be
disposed in a pouch 22.  
  
[0069] FIG. 1B depicts the pouch 22 of FIG. 1A after the tear-away
portion 36 thereof has been removed, opening the pouch 36. As
depicted, the wipe 24 has been partially removed from the pouch
22. The wipe 24 is a folded wipe with a Z-style fold, though any
suitable folded configuration may be used.  
  
[0070] FIG. 1C shows the wipe 24 of FIG. 1B having been fully
removed from the pouch 22 and substantially unfolded. The depicted
wipe 24 is generally rectangular in shape, but any suitable shape
may be used such as oval, elliptical, triangular, irregular
shapes, and so forth (not shown). The wipe 24 may have any
suitable unfolded width and length. For example, the wet wipe may
have an unfolded length of from about 2.0 to about 80.0
centimeters or from about 10.0 to about 25.0 centimeters and an
unfolded width of from about 2.0 to about 80.0 centimeters or from
about 10.0 to about 25.0 centimeters. FIG. 2 shows one version of
a container 40 holding multiple individually wrapped products 20
such as those of FIG. 1A, each having a sealed pouch 22 comprising
wet wipes (not shown) for reducing malodor, further comprising a
top end 32, a tear line 30, and a tear-away portion 36. The
container 40 may be made of paperboard, plastic, foil, foam, or
combinations thereof, and generally comprises a resilient rear
panel 42 and a pocket element 44 defining a pocket 46. A bottom
element 48 closed the bottom of the pocket 46. The pocket 46 can
receive a plurality of the individually wrapped products 20. An
optional closure element (not shown) may be attached to the rear
panel 42 or the pocket element 44 that can be folded or pivoted
over the exposed products 20 to close the container 40.  
  
[0071] The wipe 24 may comprise a basesheet with total (dry) basis
weight of from about 25 to about 120 grams per square meter and or
from about 40 to about 90 grams per square meter. The basesheet
may comprise a multilayer structure with, for example, laminated,
bonded, or adjacent layers differing in fibers (e.g., coform with
polyethylene versus coform with polypropylene or differing in the
cellulosic fibers used), fiber treatments, adhesives, etc. Coform
may be used for one or more layers or components, as described in
U.S. Pat. No. 4,100,324 to Anderson et al. which issued Jul. 11,
1978; U.S. Pat. No. 4,604,313 to McFarland et al. which issued
Aug. 5, 1986; and U.S. Pat. No. 5,350,624 which issued Sep. 27,
1994; which are herein incorporated by reference to the extent
they are consistent herewith.  
  
[0072] FIG. 3 shows a telescopic view of a portion of a wipes
container 50 showing a lower body 56 adapted to contain a stack of
wipes 24 and a cream dispenser 52 depicted here as a simple well
54 holding a quantity of cream 56 comprising a composition
effective in controlling malodor on the pudendum. The well 54 may
comprise a resilient material such as a polyolefin plastic or may
have flexible walls. The well 54 may be separable from the lower
body 56 of the wipes container 50 or may be unitary therewith,
such as a well 54 formed with the lower body 56 from plastic
injection molding (not shown). The cream dispenser 52, in other
embodiments, may be replaced with other known dispensers of
formulations, including flexible pouches (not shown) that can
release a cream by squeezing, or dispensers with mechanical means
for dispensing such as pumps (not shown).  
  
[0073] The lower body 56 has a floor 62 and side walls 60. The
lower body 56 receives the stack of wipes 24 as shown along the
telescoping axis 64A, and also receives the cream dispenser 52
along the parallel telescoping axis 64B.  
  
[0074] A covering for the container 50 is not shown, but any known
covering may be used such as a removable lid or a hinged lid
connected to or integral with the lower body 56. In use, the
covering (not shown) may be opened to allow a user to remove a
wipe 24, apply a quantity of the cream 56 to the wipe 24, and then
apply the wipe to the body.  
  
[0075] FIG. 4 shows a plan view of a wipe 24 with multiple
discrete zones 70 comprising an active ingredient for reducing
malodor. The wipe 24 itself may be a nonwoven web or other
flexible porous substrate, and may be a wet wipe impregnated with
an aqueous solution or may be a dry wipe. The discrete zones 70 in
this embodiment are shown as circles, but they may be in any
shape, size, or arrangement, such as parallel bands, irregular
patches, rectangles, lines and dashes, triangular regions, and
combinations thereof. The discrete zones 70 may comprise a cream,
ointment, lotion, or semi-solid material comprising a composition
for reducing malodor according to various embodiments described
herein, The composition may comprise an acidifying agent and may,
for example, comprise caffeine and mandelic acid in a viscous
lipophilic carrier and may have a pH from about 2.8 to about 5 or
more specifically from about 3.2 to about 4.5, and more
specifically still from 3.2 to 4.5. The discrete zones 70 may be
substantially topical relative to the wipe 24, such that a
majority of the mass in the discrete zones 70 is deposited above
the upper surface of the substrate of the wipe 24 (e.g., elevated
regions). Alternatively, the discrete zones 70 may be defined by
matter that is substantially impregnated into the wipe 24, or may
comprise both elevated regions and impregnated regions. The wipe
24 may be textured (not shown), with treated discrete zones 70
corresponding to topographical features on the wipe such as
elevated structures or depressed regions (not shown).  
  
[0076] FIGS. 5A and 5B, 6A and 6B, and 7A and 7B show experimental
results regarding the suppression of TMA production by bacteria in
the presence of choline as a function of time and as a function of
the presence of a material according to an embodiment of the
present invention. These figures are described in more detail in
the discussion of Example 6 hereafter, but do show that a
formulation according to an embodiment of the present invention is
effective in reducing TMA production by bacterial that are
frequently found on human skin.  
  
**FURTHER DETAILED DESCRIPTION**  
  
[0077] The acidifying components of the personal care composition
generally include a first alpha-hydroxy acid such as mandelic acid
(also known as phenylglycolic acid) and optionally a second
alpha-hydroxy acid composition such as lactic acid and/or other
carboxylic acids, including acids such as citric, glycolic,
2-hydroxybutyric acid, tartaric acid; gluconic acid or other
isomers of pentahydroxyhexanoic acid; hydroxycaprylic acid, leucic
acid (2-hydroxy-4-methylpentanoic acid), ethylglycolic acid, malic
acid, and the like. U.S. Pat. No. 5,091,171, aAmphoteric
Compositions and Polymeric Forms of Alpha Hydroxyacids, and Their
Therapeutic Use,a issued February, 1992 to Yu et al., describes
alpha hydroxyl acids that can be considered for use with various
embodiments of the present invention. The first alpha-hydroxy acid
may have at least 7 or at least 8 carbons for each carboxylic acid
group and may have a molecular weight from about 135 to about 400,
more specifically from about 135 to about 250, from about 135 to
about 200, or from 145 to 170. The first alpha-hydroxy acid may be
monoprotic (a monocarboxylic acid) or, in some versions, diprotic
(a dicarboxylic acid), though larger numbers of carboxylic acid
groups may be considered. In other versions, the first
alpha-hydroxy acid or both the first and second alpha-hydroxy acid
may have a molecular weight of 90 or greater, 100 or greater, 120
or greater, 150 or greater, or 160 or greater. The first
alpha-hydroxy acid also may have at least one aromatic ring such
as a phenyl group. (Mandelic acid is the smallest alpha hydroxyl
acid with an aromatic ring.) Without wishing to be bound by
theory, it is believed that the first alpha-hydroxy acid as
described is large enough to not rapidly penetrate into the
stratum corneum of the skin, allowing it to remain present and
active on the surface of the skin for a prolonged period of time,
while it is also small enough to be biologically active to modify
the bacterial environment on the skin and/or to maintain an acidic
condition on the surface of the skin. The relatively high
molecular weight and larger number of carbons per acid group in
such acids may also reduce the potential for irritation to the
skin.  
  
[0078] In some embodiments, other alpha-hydroxy acids comprising
aromatic rings may be used, including derivatives of mandelic acid
such as those described in U.S. Pat. No. 6,777,224, aMethod for
Producing Optically Active Mandelic Acid Derivatives,a issued Aug.
17, 2004 to Mitsuhashi et al., or the dimmers and other
derivatives described in U.S. Pat. No. 5,932,619, aMethod for
Preventing Sexually Transmitted Diseases,a issued Aug. 3, 1999 to
Zaneveld et al., both of which are herein incorporated by
reference to the extent that it is noncontradictory herewith.  
  
[0079] The second alpha-hydroxy acid composition may, in some
embodiments, help improve the efficacy of the first alpha-hydroxy
acid while also contributing to desired acidity on the skin and
optionally may also have an antimicrobial effect relative to
unwanted bacteria that otherwise could contribute to an undesired
fishy odor. The second alpha-hydroxy acid composition may comprise
alpha-hydroxy acids having, individually or averaged, a molecular
weight of about 170 or less, such as from 75 to 135, from 75 to
125, or from 80 to 85, or from 86 to 92.  
  
[0080] The alpha-hydroxy acids in total may be present in any
suitable concentration, such as 30% by weight or less, 20% by
weight or less, or 10% by weight or less, and more specifically
from about 0.3% to 10% (percentages in reference to chemical
compositions herein will be understood to be weight percent unless
otherwise indicated), from about 0.5% to about 6%, from about 1%
to about 15%, or from about 0.5% to about 3.5%, or from about 0.1%
to about 2.5%.  
  
[0081] In one version, the second alpha-hydroxy acid composition
comprises at least about 30%, at least about 50%, at least about
70% or at least about 93% lactic acid by weight (i.e., weight %)
of lactic acid, such as from about 30% to about 90%, or from about
50% to about 95%; or from about 50% to about 95% lactic acid by
weight. In one version, the second alpha-hydroxy acid is
substantially all lactic acid.  
  
[0082] Examples of formulations can include lotions, creams, gels,
wipe solutions, sprays, powders, etc., with the following
acidifying compositions, expressed as weight percents: 1.5% lactic
acid and 0.5% mandelic acid; 2.5% lactic acid and 1% mandelic
acid; 25% lactic acid and 2% mandelic acid; 10% lactic acid and
10% mandelic acid; 5% lactic acid and 4% mandelic acid; etc.  
  
[0083] The alpha-hydroxy acids may, at least in part, be provided
in time-release systems that gradually release the alpha-hydroxy
acid to be effective in controlling the pH of the pudendum.
Time-release technology can include microencapsulation and other
systems known in the art. Time-release or other controlled release
means are well known in the art. Some versions, by way of example,
are described in U.S. Pat. No. 5,756,136, aControlled Release
Encapsulation Compositions,a issued May 26, 1998 to Black et al.;
and U.S. Pat. No. 6,835,397, aControlled Release Encapsulated
Bioactive Substances,a issued Dec. 28, 2004 to Lee et al.; both of
which are herein incorporated by reference to the extent that they
are noncontradictory herewith.  
  
[0084] In many embodiments, the formulations and methods disclosed
herein avoid the problems of stinging or other forms of irritation
that are known in some prior products. Sting-free formulations,
for example, may be substantially free of ethanol, propanol, or
other agents that may sting delicate tissues in the pudendal
region.  
  
[0085] While the products and methods described herein are
particular suited for controlling unwanted fishy odor from the
pudendum of adult or teenaged females, they may also be adapted
for males in general, such as adult males. They may also be
adapted for children in general, such as infants and toddlers.  
  
**Absorbent Articles**  
  
[0086] A wide variety of absorbent articles may be used to deliver
formulations or assist in modifying the conditions of the pudendum
to inhibit odor formation and release. Absorbent articles can
include feminine pads, interlabial devices, tampons, incontinence
devices such as diapers and related articles, briefs, panties, and
the like. Description of exemplary products can be found in, by
way of example only, the following: U.S. Pat. No. 7,201,743,
aIncontinence Diaper for Adults,a issued Apr. 10, 2007 to Rohrl;
U.S. Pat. No. 6,454,751, aAbsorbent Articles Having Hinged
Fasteners,a issued Sep. 24, 2002 to Olson; U.S. Pat. No.
5,830,206, aPants-Type Diaper or Sanitary Panty,a issued Nov. 3,
1998 to Larsson; U.S. Pat. No. 5,620,432, aTape tab fasteners for
disposable absorbent articles,a issued Apr. 15, 1997 to Goulait et
al.; U.S. Pat. No. 6,620,146, aAdult Incontinence Article with
Body-Shaping Elastics,a Sep. 16, 2003 to Gibbs; U.S. Pat. No.
6,375,646, aAbsorbent Pants-Type Diaper,a issued Apr. 23, 2002 to
Widlund et al.; U.S. Pat. No. 2,092,346, aCatamenial Pad,a issued
to Arone on Sep. 7, 1937; U.S. Pat. No. 3,905,372, aFeminine
Hygiene Protective Shield,a issued to Denkinger on Sep. 16, 1975;
U.S. Pat. No. 2,662,527, aSanitary Pad,a issued to Jacks on Dec.
15, 1953; U.S. Pat. No. 4,631,062, aLabial Sanitary Pad,a issued
to Lassen et al. on Dec. 23, 1986; all of which are herein
incorporated by reference to the extent that it is
noncontradictory herewith.  
  
[0087] Disposable absorbent articles generally have a body facing
intake layer comprising a porous web or film, an absorbent core,
and an impervious backsheet, with other optional components as is
known in the art. In some versions, the intake layer is integral
with the absorbent core or is not present as a distinct separate
component. In some versions, the backsheet is integral with the
absorbent core or similar functionality is provided by treating
the absorbent core with, for example, a hydrophilic material on
the outer surface.  
  
[0088] The absorbent core can be made of any suitable
liquid-absorbent materials such as comminuted wood pulp that is
generally referred to as airfelt, as well as materials such as
cotton; creped cellulose wadding; meltblown polymers including
composites with wood fibers such as coform; chemically modified or
cross-linked cellulosic fibers; synthetic fibers such as
bicomponent spunbond or crimped polyester fibers; peat moss;
tissue materials including tissue wraps and tissue laminates;
absorbent foams; absorbent sponges; superabsorbent polymers;
absorbent gelling materials; or any equivalent material or
combinations of materials, or mixtures of these. The absorbent
materials may comprise folded tissues, woven materials, nonwoven
webs, needle punched rayon, and thin layers of foam. Absorbent
portions of the product may comprise a single material or a
combination of materials, such as a wrapping layer surrounding a
central wadding comprised of a different material.  
  
[0089] The backsheet may comprise a woven or nonwoven material,
polymeric films such as thermoplastic films of polyethylene or
polypropylene, or composite materials such as a film-coated
nonwoven material. It may be flexible and adapted to fit into or
attach to undergarments such as panties. It may be provided with
adhesive material and may have tabs for wrapping around the sides
of undergarments. Other attachment means that may cooperate with
or attach to the backsheet may be used such as hook and loop
attachment or other mechanical attachment means, coadhesive
materials, snaps, belts, ligaments, and the like.  
  
[0090] Methods of applying the acidifying compositions to the
absorbent articles include spraying, blade coating, contact
coating, curtain coating, application with metered rods,
flexographic printing, gravure printing, ink-jet printing, other
digital printing techniques, and other known methods.  
  
[0091] Lotioned topsheets and methods of manufacturing them are
described in US 20040064117, aAbsorbent Article Having a Lotioned
Topsheet,a published Apr. 1, 2004 by Hammons et al., herein
incorporated by reference to the extent that it is
noncontradictory herewith.  
  
[0092] U.S. Pat. No. 6,118,041, aDiaper Having a Lotioned
Topsheet,a issued Sep. 12, 2000 to Roe et al., herein incorporated
by reference to the extent that it is noncontradictory herewith,
describes an absorbent article worn next to the skin of a user
that can transfer a lotion on the topsheet of the article to the
skin of the wearer. In one version, the Roe patent describes an
absorbent article with a topsheet having a lotion coating which is
semi-solid or solid at 20A deg C. and which is partially transferable
to the wearer's skin, the lotion coating comprising from about 10
to about 95% of a substantially water free emollient having a
plastic or fluid consistency at 20A deg C., wherein the emollient
contains about 5% or less water and emollient comprising a member
selected from the group consisting of petroleum-based emollients,
fatty acid ester emollients, alkyl ethoxylate emollients, and
mixtures thereof, further comprising from about 5 to about 90% of
an agent capable of immobilizing the emollient on said outer
surface of the topsheet, wherein the immobilizing agent has a
melting point of at least about 35A deg C. and is miscible with the
emollient.  
  
[0093] The immobilizing agent may comprise a member selected from
the group consisting of waxes, polyhydroxy fatty acid amides,
C14-C22 fatty alcohols, C12-C22 fatty acids, C12-C22 fatty alcohol
ethoxylates having an average degree of ethoxylation of about 2 to
about 30, and mixtures thereof. The natural fats or oils of the
oil-in-water emulsion composition may be selected from the group
consisting of: avocado oil, apricot oil, babassu oil, borage oil,
camellia oil, canola oil, castor oil, coconut oil, corn oil
cottonseed oil, evening primrose oil, hydrogenated cottonseed oil,
hydrogenated palm kernel oil, maleated soybean oil, meadowfoam
oil, palm kernel oil, phospholipids, rapeseed oil, palmitic acid,
stearic acid, linoleic acid, stearyl alcohol, lauryl alcohol,
myristyl alcohol, benenyl alcohol, rose hip oil, sunflower oil,
soybean oil, and mixtures thereof. The amount of said fats or oils
used in the composition may be from about 0.5 to about 10% by
weight, and more preferably from about 1 to about 5% by weight.  
  
[0094] U.S. Pat. No. 5,607,760 to Roe, herein incorporated by
reference to the extent that it is noncontradictory herewith,
describes a lotion coating on the outer surface of the non-woven
top sheet of an absorbent article, such as diapers, pull-on
products, adult incontinence devices, and the like. A waterless
lotion composition is reported to convey a desirable therapeutic
or protective coating benefit and to be effective in reducing the
adherence of bowel movement to the skin. The lotion is solid or
semi-solid at 20A deg C. with a preferred melting point of about 45A deg
C. In one version of a process for the application of the lotion
to a substrate, the lotion composition is placed in a heated tank
operating at a suitable temperature such as about 63A deg C., then
sprayed onto the substrate by a spray head operating at a warmer
temperature such as about 71A deg C. In some versions, the system of
Roe can be adapted for application of formulations to prevent
fishy odor described herein.  
  
[0095] Absorbent articles capable of transferring a coated or
impregnated material to the body of the wearer may be made
according to the principles described in any of the following US
patents: U.S. Pat. No. 3,860,003 issued to Buell on Jan. 14, 1975;
U.S. Pat. No. 5,151,092 issued to Buell et al. on Sep. 29, 1992;
U.S. Pat. No. 5,221,274 issued to Buell et al. on Jun. 22, 1993;
U.S. Pat. No. 4,988,344 entitled aAbsorbent Articles with Multiple
Layer Absorbent Layersa issued to Reising, et al on Jan. 29, 1991
and U.S. Pat. No. 4,988,345 entitled aAbsorbent Articles with
Rapid Acquiring Absorbent Coresa issued to Reising on Jan. 29,
1991.  
  
[0096] U.S. Pat. No. 3,896,807 to Buchalter describes an article
impregnated with a solid oil phase of cream formulation which
forms a cream upon addition of moisture thereto. In related
adaptations, the approach of Buchalter could be used to provide a
cream that becomes further activated by body moisture.  
  
[0097] U.S. Pat. No. 3,489,148 to Duncan et al. teaches a baby
diaper comprising a hydrophobic and oleophobic topsheet wherein a
portion of the topsheet is coated with a discontinuous film of
oleaginous material.  
  
**Wipes**  
  
[0098] Wipes, whether dry, wet, or in other states, can be made
from any suitable substrate that provide a flexible surface useful
in applying compositions described herein. The wipe may be a
porous, flexible wet wipe capable of retaining and applying a
liquid solution, or may be flexible dry wipe that can apply a
viscous formulation form its surface onto the pudendum. Suitable
materials may include nonwoven or woven fabrics, tissue paper,
composite or multilayered materials, etc, The wipe may be made
from a conventional towelette or wet wipe material or other
materials that have been proposed for wipes such as a nonwoven
fabric including materials such as spunbond webs, meltblown webs,
combinations of polymeric and natural fibers such as spunlace or
coform webs, needlepunched webs, hydroentangled or spunlace
materials, bonded carded webs, electrospun layers, composites or
multilayer fabrics, woven textiles, apertured films, and the like.
Polymeric materials used in the production of nonwoven webs, woven
webs, and films may include polypropylene, polyethylene, PET,
nylons, and the like. Foam pads or layers may be used, including
open cell and closed cell foams, such as polyurethane foams,
regenerated cellulose foams, and the like.  
  
[0099] Examples of materials that may be used in producing wipes
as described herein include those disclosed in any of the
following, alone or in combination: U.S. Pat. No. 5,935,880,
aDispersible Nonwoven Fabric and Method of Making Same,a issued
Aug. 10, 1999 to Wang et al.; U.S. Pat. No. 6,315,864, aCloth-Like
Base Sheet and Method for Making the Same,a issued Nov. 13, 2001
to Anderson et al.; U.S. Pat. No. 6,416,623, aMethod of Producing
an Extensible Paper Having a Three-Dimensional Pattern and a Paper
Produced by the Method,a issued Jul. 9, 2002 to Hollmark et al.;
U.S. Pat. No. 6,737,068, aWipe Formulation,a May 19, 2004, issued
to Durden; U.S. Pat. No. 7,482,021, aTwo-Sided Wipe for Cleaning
and Drying a Skin Surface,a issued Jan. 27, 2009 to Tison et al.;
US 20020155281, aPre-Moistened Wipe Product,a published Oct. 24,
2002 by Lang et al. US; US 20040161991, aNon-Woven Wet Wiping,a
published Aug. 19, 2004 by Walton et al.; US 20050045293, aPaper
Sheet Having High Absorbent Capacity and Delayed Wet-Out,a
published Mar. 3, 2005 by Hermans et al.; all of which are herein
incorporated by reference to the extent that they are
noncontradictory herewith.  
  
[0100] Wipes for use with the formulations described herein may
also be made, used, or dispensed according to any of the
following: U.S. Pat. No. 5,292,581, aWet Wipe,a issued Mar. 8,
1994 to Viazmensky et al.; and U.S. Pat. No. 6,537,631, aRoll of
Wet Wipes,a issued Mar. 25, 2003 to Rivera et al., all of which
are herein incorporated by reference to the extent that they are
noncontradictory herewith.  
  
[0101] Wipes may be provided from or in association with
dispensers that provide a quantity of a formulation as described
herein useful in preventing or reducing odor from the pudendum.
Such a dispenser can include a combination of wipe dispenser and
spray applicator for dispensing active ingredients, as described,
for example, in US 20090057331, aWipes Dispenser,a published Mar.
5, 2009 by Fryan et al., herein incorporated by reference to the
extent that it is noncontradictory herewith. Wipes be dispensed
from containers such as plastic or metal tubs or cylinders, from
flexible pouches such as resealable pouches, form cardboard or
other cellulosic containers, and from other known devices for
dispensing wipes. U.S. Pat. No. 6,601,737, aBaby Wipe/Rash Cream
Dispenser,a issued Aug. 5, 2003 to Gartenberg, herein incorporated
by reference to the extent that it is noncontradictory herewith,
can also be adapted to dispense an effective quantity of a viscous
composition comprising acidifying agents for the reduction of
fishy odor when applied to the pudendum, such that the viscous
composition can be applied to a wipe from the dispenser to assist
in application of the formulation to the pudendum. The wipes may
be wet or dry wipes, and may be pretreated with cleansing
compositions, fragrance, and the like, which can be applied in
addition to the acidifying composition.  
  
[0102] In one embodiment, individually enclosed wipes are
provided, similar to known towelettes such as those discussed in
WO/2003/051227, aFeminine Wipe for Symptomatic Treatment of
Vaginitis,a published Jun. 23, 2003 by Syed Rizvi, herein
incorporated by reference to the extent that it is
noncontradictory herewith. Such individual wipes may have
dimensions such as 8A5.25 inch rectangles, or more generally,
rectangles or other shapes with a first dimension and a second
orthogonal dimension generally aligned with the major axes of the
shape (e.g., the length of the sides of a rectangle) ranging from
about 4 cm to about 40 cm, or from about 9 cm to about 30 cm. The
aspect ratio (e.g., the length divided by the width, with the
longer dimension being taken as the length) may be about 1, or
from about 1 to about 1.6, or from about 1 to about 2.5, or about
1.1 or greater, or less than 3, by way of example. The wipe may be
folded into smaller dimensions prior to use, and ma be packaged or
stored prior to consumer purchase with individual folded wipe
dimensions with first and second orthogonal dimensions ranging
from about 2 cm to about 18 cm, or from about 4 cm to about 12 cm,
or less than about 13 cm, with an aspect ratio of from about 1, or
from about 1 to about 1.6, or from about 1 to about 2.5, or about
1.1 or greater, or less than about 2. A pouch into which a folded
wipe is placed may have similar but slightly greater dimensions
than the wipe itself, with at least one dimension of the pouch
being larger than the corresponding dimension of the wipe
contained therein by no more than about 5%, about 10%, about 15%,
or about 25% of the corresponding dimension of the wipe. The
amount of fluid contained in the pouch may equal the amount of
fluid that a saturated or less-than-saturated wipe can hold and
may be carried completely by the wipe during manufacturing (i.e.,
no additional fluid is added to the pouch beyond what is carried
by the wipe itself). Alternatively, the pouch may contain
additional fluid that is placed in the pouch in addition to what
the wipe carries prior to contact with the pouch, or the wipe may
be substantially dry prior to placement in the pouch and may then
be combined with fluid prior to sealing of the pouch.  
  
[0103] In yet another version, a substantially dry wipe may be
placed in a sealed pouch, after which liquid is injected or
otherwise introduced into the pouch via, for example, a one-way
flow valve or other means, optionally followed by additional
sealing to prevent leakage. The amount of fluid in the pouch may
range, by way of example, from 1 ml to 50 ml, from 2 ml to 25 ml,
or from 5 ml to 10 ml. Alternatively, the amount of liquid present
in the pouch or in any wipe may have a mass equal to about 10% or
more, about 30% or more, about 60% or more, about 80% or more,
from about 30% to about 300%, from about 50% to about 200%, or
from about 70% to about 150%, of the mass of the dry wipe.  
  
[0104] In one embodiment, the wipes are delivered in a flexible or
rigid container integral with a formulation dispenser for applying
an odor-controlling low-pH formulation on the wipes or the
pudendum directly. The formulation dispenser can be a tab or other
closure element on a pouch that contains a viscous composition
that can be squeezed out through an opening onto a wipe or onto
the fingers. In a related embodiment, the opening of a tab to
access the contents of a container of wipes may also open a seal
for a quantity of a viscous formulation to be applied to the wipe.  
  
**Other Product Forms**  
  
[0105] A variety of other product forms can be considered.
Single-use sponges in individual wraps can be used, for example,
with instructions and indicia similar to those for wipe products.
The sponge may be polyurethane, regenerated cellulose, and other
known sponge materials. The compositions described herein may be
impregnated in the sponge or applied shortly prior to use. One
example of related materials that can be adapted for use with the
compositions described herein are the vaginal prep sponges
marketed by McKesson. The sponges may be attached to a wand that
can be held by the hand to apply the sponge to the pudendum
conveniently. The wand may be a plastic, paper, or wooden handle.
The wand and sponge may be wrapped in foil or plastic that is
removed prior to use. The dimensions of the sponge may be about 3
cm to 8 cm by about 2 cm to 5 cm by about 1 cm to 3 cm. The sponge
may have a raised area for gripping in the center.  
  
[0106] Sponges on a wand could be used for external use as well as
internal/vaginal use, particular if using a non shedding sponge
material saturated with solution to cleanse the vagina after
intercourse or at the tail end of menses.  
  
[0107] Saturated cotton swabs (i.e., cotton-tipped swabs) can also
be used to deliver the compositions described here. The size of
the swab may be about 2A3 cm in size, for example, and may have a
2- to 8-mm diameter applicator stick such as a 3-mm applicator
stick. The swab may packaged in a foil pack with the swab
preloaded with the composition. Swabs may be used, for example,
for convenient application to the interlabial folds, and may be
particularly useful for women that have deep folds. Cotton balls,
textiles, foam pads, or other porous substrates may also be used,
and may be impregnated with a composition effective for
controlling malodor, as described herein, or may be provided with
a container of a composition for controlling malodor, such that
the porous substrate can receive an quantity of the composition
and then transfer it to the pudendal region.  
  
[0108] Spray bottles may be used, for example, for application of
the compositions described herein for post intercourse or bowel
movement and also for postpartum treatments after childbirth. For
example, an accordion pleated plastic bottle could be provided
with a tablet inside with an effervescent composition that rapidly
dissolves when water is added. After adding water, the product
could function like a bidet in a bottle. Such a bottle could be
collapsed when empty for convenience storage and reuse. The abidet
tabletsa and bottles could be provided separately (e.g., the
tablets could be provided in a blister pack).  
  
[0109] In another embodiment, the compositions describes herein
could be provided on a porous web such as a nonwoven web or paper
web, including substrates similar to those used for dryer sheets
in clothing care. The weblike substrate pretreated with the active
ingredients useful for controlling fishy odor may be dry initially
but activated with moisture, or may be provided in an emulsion or
ointment that does not require significant moisture to become
effective in controlling pH on the pudendum. The sheet may be
wrapped around, placed in, or attached to a feminine pad,
underwear or other article that is placed adjacent to the
pudendum.  
  
[0110] In one version, active ingredients described herein are
applied to tissue paper marketed as toilet paper, such as a toilet
paper for female use. In wiping, small quantities of pH
controlling agents can be left on the pudendum to control the pH
thereon and mitigate fishy odor or other malodors. In one related
embodiment, ahis and hersa rolls of toilet paper can be marketed
in which the ahersa rolls are pretreated with a composition for
delivering one or more alpha-hydroxy acids such as mandelic acid
for use in controlling malodor arising from the pudendum.  
  
[0111] Feminine pads or wipes can also be provided that can be
held or placed in contact with the pudendum for a short period of
time such as about 2 hours or less, about 1 hour or less, about 30
minutes or less, or about 10 minutes or less, such as about 10
minutes to 60 minutes or about 15 minutes to about 45 minutes.
Such pads or wipes may be adapted to fit into the folds of the
pudendum to deliver active ingredients for pH control. A
pretreated wipe may be placed on another pad or other article for
improved contact.  
  
[0112] Active ingredients in powder form may be delivered in a
spray such as a propellant-delivered powder spray may be directed
to spray an article such as the crotch of underwear or the
pudendum-contacting portion of an absorbent article, or may be
used to spray directly on the body. Propellant-free application
using a manually operated pump may be considered, wherein air, for
example, entrains particulates in the dry powder.  
  
[0113] Tampons may also be considered. Such tampons may be
provided with powder in the core of the tampon.  
  
[0114] The products and methods of the present invention may also
be adopted in combination with other known treatments, such as the
treatments for vulvar dystrophy described in U.S. Pat. No.
4,150,128, aMethod of Treating Atrophic Vulvar Dystrophy,a issued
Apr. 17, 1979 to Jasionowski, herein incorporated by reference to
the extent that it is noncontradictory herewith. Jasionowski
describes pharmaceutical formulations comprising a
pharmaceutically acceptable hydrophilic ointment base containing a
suspension of progesterone (Pregn-4-ene, 3,20-dione) or other
progestins dissolved in vegetable oil is topically applied to an
area afflicted with vulvar dystrophy. Plant estrogens, including
those obtained from soy and black cohosh, may also be considered.  
  
[0115] Many alternate product formats can be considered. For
example, the compositions of the present invention may be provided
not only in wipes or creams, but also as vaginal suppositories to
provide ongoing release of active ingredients for the pudendal
area. The compositions of the present invention may also be
applied to absorbent articles such as sanitary napkins, feminine
pads, incontinence pads, pantiliners, tampons, and the like. The
compositions of the present invention may be delivered via wet
wipes, wetted sponges, strips of nonwoven materials or other
flexible materials attached to the underwear or temporarily held
or wiped against the body, etc. The compositions may also be
delivered by means of an aerosol spray, a non-aerosol spray such
as a manually pumped spray bottle, a roller with a rolling head
that delivers liquid ingredients from a liquid reservoir, a gel
stick, and the like, including, for example, a tubular delivery
device with a twist-click elevator mechanism in which turning of a
lower portion of the device ratchets up an elevator that expels a
cream or gel from an orifice on a delivery head for application to
the body.  
  
[0116] The feminine treatment composition may be applied in a
variety of means to deliver active ingredients to the exterior
surface of the user. These delivery means may include feminine
pads (a term intended to comprise sanitary napkins, pantiliners,
thong liners, and a variety of menstrual pads and incontinence
products). The delivery means may also comprise wipes,
particularly wet wipes, that are used to deliver active
ingredients in a formulation to the exterior body of the user in
the pudendum or adjacent regions. Moist or pretreated liners may
also be placed in contact with the body for a period of time,
similar to or in conjunction with the use of feminine pads (e.g.,
pantiliners). These may be applied during the day, including
throughout the day or for brief periods of time, such as for 1
minute or longer, 5 minutes or longer, or 20 minutes or longer,
including, for example from 10 minutes to 12 hours, from 1 hour to
6 hours, or for about 1 hour to 24 hours, or less than about any
of the following: 24 hours, 6 hours, 2 hours, 1 hours, 10 minutes,
5 minutes, 1 minute, 30 seconds, or 15 seconds.  
  
[0117] The feminine treatment composition may be generally applied
in any known form such as in the form of a spray or a viscous
formulation for application by means other than conventional
spraying. Such a viscous formulation may comprise a cream
(generally understood to comprise an emulsion such as an oil/water
emulsion, including oil-in-water and water-in-oil emulsions) such
as those that may be described as a moisturizer, lotion, liniment,
ointment, salve, etc. The viscous formulation may also appear to
be a jelly, including a single-phase or multi-phase viscous fluid
such as a gel optionally displaying viscoelasticity. The viscous
formulation may be characterized by being flowable under shear
stress, but may have a yield stress such that at very low shear
stress levels, the formulation substantially does not flow. In
some cases, the yield stress may be sufficiently high such that a
quantity of the viscous formulation at room temperature (22A deg C.)
maybe applied to a substantially vertical section of human skin
without immediately and noticeably flowing under the influence of
gravity alone (specifically, the quantity may be sufficient to
coat a 3 cm diameter circular section of dry, glabrous skin such
as skin on the upper thigh to a depth of about 2 mm without
visible migration of the viscous formulation after 3 minutes of
gravitation pull while the skin is held substantially still in a
vertical orientation). The viscous formulation may also comprise a
substantial quantity of void space or gaseous bubbles and may be
in the form of a foam, a multiphase gel, etc. The formulation may
also be provided as a solid or semisolid material such as a
soluble polymeric film or other film capable of releasing active
ingredients in use, including films comprising slow-release
polymeric substrates. Slow-release polymers for releasing active
ingredients may be used in any other known form as well. The
formulation may also be provided as a wash, as a douche product,
as a suppository, as a coating, liquid, vaginal capsule, vaginal
tablet, vaginal film, vaginal sponge, vaginal ovule, etc.,
provided that it is adapted to release active ingredients to the
exterior skin of the user. The formulation may also be applied to
a vaginal insert, tampon, wipe or pad, and then administered to
the vagina, provided that active ingredients can be delivered
therefrom to the exterior surfaces of the body adjacent the
vagina.  
  
[0118] For formulations comprising gels, although a variety of
compounds may be employed, water is usually employed as the
dispersion medium for the gel to optimize biocompatibility. Other
possible dispersion mediums include non-aqueous solvents,
including glycols, such as propylene glycol, butylene glycol,
triethylene glycol, hexylene glycol, polyethylene glycols,
ethoxydiglycol, and dipropyleneglycol; alcohols, such as ethanol,
n-propanol, and isopropanol; triglycerides; ethyl acetate;
acetone; triacetin; and combinations thereof. Typically, the
dispersion medium (e.g., water) constitutes greater than about 75
wt/vol %, in some embodiments greater than about 90 wt/vol %, and
in some embodiments, from about 95 wt/vol % to about 99 wt/vol %
of the vaginal treatment composition.  
  
[0119] The disperse phase of the gel may be formed from any of a
variety of different gelling agents, including temperature
responsive (athermogellinga) compounds, ion responsive compounds,
and so forth. Thermogelling systems, for instance, respond to a
change in temperature (e.g., increase in temperature) by changing
from a liquid to a gel. Generally speaking, the temperature range
of interest is from about 25.degree. C. and 40.degree. C., in some
embodiments from about 35.degree. C. and 39.degree. C., and in one
particular embodiment, at the human body temperature (about
37.degree. C.). Compositions that change state at about this
temperature are useful because they will remain in a body cavity,
for example, after they have been delivered. Any of a variety of
thermogelling compounds that are capable of gelling when applied
to the vagina may be used in the present invention. In some cases,
thermogelling block copolymers, graft copolymers, and/or
homopolymers may be employed. For example, polyoxyalkylene block
copolymers may be used in some embodiments of the present
invention to form a thermo-gelling composition. The term
apolyoxyalkylene block copolymersa refers to copolymers of
alkylene oxides, such as ethylene oxide and propylene oxide, which
form a gel when dispersed in water in a sufficient concentration.
Some suitable polyoxyalkylene block copolymers include
polyoxybutylene block copolymers and
polyoxyethylene/polyoxypropylene block copolymers (aEO/POa block
copolymers), such as described in U.S. Patent Application
Publication No. 2003/0204180 to Huang, et al., which is
incorporated herein in its entirety by reference thereto for all
purposes. For instance, exemplary polyoxyalkylene block copolymers
include polyoxyethylene/polyoxypropylene block copolymers (EO/PO
block copolymers), etc.  
  
[0120] Any suitable gelling agent, including gellan and other
polymers and polysaccharides, may be used, including those
described in U.S. Pat. No. 7,619,008, aXylitol for Treatment of
Vaginal Infections,a issued Nov. 17, 2009 to Yang et al., herein
incorporated by reference to the extent that it is
noncontradictory herewith.  
  
**Preservatives and Antimicrobial Agents**  
  
[0121] Additional preservatives or antimicrobial agents may be
provided in the formulations and systems described herein. Such
agents may include cetylpyridinium chloride, parabens e.g.,
(methyl paraben, ethyl paraben), imidazolidinyl urea, propyl
benzoate, sodium benzoate, potassium sorbate, and the like. Other
antimicrobial or bacteriostatic agents that may be considered
include, by way of example only, biguanide, chitosan derivatives,
silver nanoparticles or other silver-based compositions and
products capable of releasing silver ions, and the like. Nisin, a
polycyclic peptide antibacterial agent, may also be incorporated.  
  
**Rheology Modifying Ingredients**  
  
[0122] Many known rheology modifiers can be considered to obtain
desired properties, particularly the bioadhesive properties of
some embodiments. Gums such as guar gum or xanthan gum or other
industrial gums, polyvinyl alcohols, polyacrylates,
cellulose-derived polymers such as carboxymethylcellise or
hydroxyalkylcellulose polymers, Laponite, clays, carboxomer
polymers, and numerous other compounds can be considered. Silicone
elastomers can be considered, including those described in U.S.
Ser. No. 09/613,266 (P&G).  
  
[0123] Known bioadhesive polymers may be used as part of the
carrier system, including polyolprepolymers from Barnet Products
Group (Englewood Cliffs, N.J.) and related compounds such as
Barnet's TopicareA(r) Delivery Compounds and related liquid polymers.
Barnet's polyolprepolymers are polyalkalene glycol-based
polyurethane polymers suitable for use as skin care agents that
can hold active ingredients on the surface of the skin. They do
not absorb substantially into the skin and can remain in place for
a prolonged period of time, being capable of forming a liquid
reservoir on the skin. Specific products include
polyolprepolymer-2 (PP-2), polyolprepolymer-14 (PP-14), and
polyolprepolymer-15 (PP-15). PP-2 is a lipophilic mixture of
liquid hydroxy-terminated polymers in polypropylene glycol having
oligomers with a molecular weight range of 1,500 to 10,000 and an
average molecular weight of about 4,000 and an HLB in the range of
12-14. At 35A deg C., it has a reported viscosity of about 2500 to
4000 cps. PP-14 is similar but has a higher molecular weight of
about 18,000 and is more lipophilic. It has an HLB of about 11-13.
At 35A deg C., it has a reported viscosity of about 2500 to 6000 cps.
PP-15 is a mixture of liquid hydroxy-terminated polymers in
polyethylene glycol. It has a molecular weight of about 1,800 and
is soluble in water and alcohol and can be used in aqueous systems
with hydrophilic components. At 35A deg C., it has a reported
viscosity of about 2500 to 5000 cps.  
  
[0124] The aforementioned polyolprepolymers are believed to be
particularly useful in enhancing the efficacy of active
ingredients such as alpha-hydroxy acids by holding them on the
epidermis level and reducing irritation.  
  
[0125] Bioadhesive materials useful for some of the embodiments
described herein may include those discussed in U.S. Pat. No.
6,479,045, aVaginal pH Buffering for Preventing Miscarriage and
Premature Labor, by Treating or Preventing Bacterial Vaginosis,a
published Nov. 12, 2002 by Bologna et al. The Bologna patent
discusses water-insoluble but water-swellable cross-linked
polycarboxylic acid polymers that may be used in vaginal
treatments. For some versions of the present materials and
methods, the bioadhesives may be modified to comprise suitable
alpha hydroxy acids and other agents, and then marketed as a
solution for the problem of fishy odor by application to the
pudendum as opposed to the vagina.  
  
**Skin Benefit Agents**  
  
[0126] Non-limiting examples of skin benefit agents that may be
considered for use herein are described in The CTFA Cosmetic
Ingredient Handbook, 2nd Edition (1992), which includes a wide
variety of ingredients commonly used in the skin care industry,
and which may be suitable for use in various embodiments of the
present invention. Non-limiting examples of skin benefit agents
include absorbents, aesthetic components such as fragrances,
pigments, natural extractives such as witch hazel or aloe vera,
colorings/colorants, essential oils, skin sensates, astringents,
etc. (e.g., clove oil, menthol, camphor, eucalyptus oil, eugenol,
menthyl lactate, witch hazel distillate), anti-caking agents,
antimicrobial agents (e.g., iodopropyl butylcarbamate),
antioxidants, colorants, cosmetic astringents, cosmetic biocides,
drug astringents, external analgesics, opacifying agents, pH
adjusters, skin-conditioning and/or moisturizing agents, i.e.
glycerine, skin soothing and/or healing agents (e.g., panthenol
and derivatives (e.g., ethyl panthenol), pantothenic acid and its
derivatives, allantoin, bisabolol, and dipotassium
glycyrrhizinate), retinoids, (e.g. retinol palmitate), tocopheryl
nicotinate, skin treating agents, vitamins and derivatives
thereof. It is to be understood that the actives useful herein can
in some instances provide more than one benefit or operate via
more than one mode of action. Therefore, classifications herein
are made for the sake of convenience and are not intended to limit
the active to that particular application or applications listed.  
  
[0127] Moisturizers may include urea, which may also be used in
combination with lactic acid for effective moisturizing activity.  
  
**Foam Embodiments**  
  
[0128] In some embodiments, the active ingredients are delivered
to the body while in a foam state, such as stable foam, for
example, that is produced with or without a propellant. In some
versions, a foam is dispensed from a dispenser such as a
propellant-free dispenser with pumping action to create the foam
from a composition in a foamable carrier, and then applied to a
wipe or other substrate, or applied to the hand of the user or
otherwise delivered to the pudendum. Propellant-driving foam
generators may also be used to deliver the composition as a foam.  
  
[0129] Active ingredients in a foam may be dispensed for
subsequent placement on a dry wipe, a pre-moistened wipe, or other
soft, flexible applicator (e.g., an object about 3-fingers wide or
4 to 10 cm wide) or a finger condom wipe or other object to used
for application of the foam-based composition to the pudendum. The
foam can be a non-propellant foam. A foam with a suitable
stiffness of yield stress can be applied to the pudendum in any
manner of methods for sustained body adherence.  
  
[0130] Examples of foam-based systems are described in U.S. Pat.
No. 6,818,204, aStable Foam for Use in Disposable Wipe,a issued to
Lapidus on Nov. 16, 2004, herein incorporated by reference to the
extent that it is noncontradictory herewith. The Lapidus patent,
whose teachings may be adapted for use with the present products
and processes, discusses the use of compatible surfactants, e.g.,
nonionic, anionic, amphoteric, for use in human hygienic products.
The surfactant should be capable of forming a foam when mixed with
air in a finger actuated, mechanical pump foamer. Such surfactants
are said to include, without limitation, those which do not
irritate mucous membranes such as polyethylene 20 cetyl ether
(Brij 58)acent, a nonionic surfactant; sodium lauroyl sarcosinate
(Hamposyl L-30)acent, sodium lauryl sulfoacetate (Lathanol LAL)acent and
sodium laureth sulfate (Sipon ESY)acentaanionic surfactants;
lauramidopropyl betaine (Monateric LMABacent), an amphoteric
surfactant, as well as polysorbate 20, TEA-cocoyl glutamate,
disodium cocoamphodiacetate and combinations thereof. Typically,
the surfactant is said to present in an amount from about 2% to
about 35% by weight, or from about 5% to about 15% by weight.  
  
[0131] At least one foam stabilizing agent may also be present in
certain foamable embodiments. Suitable foam stabilizing agents may
include, without limitation, natural or synthetic gums such as
xanthan gum, polyalkylene glycols such as polyethylene glycol,
alkylene polyols such as glycerine and propylene glycol and
combinations thereof. Typically, the foam stabilizers may be
present in an amount from about 0.10% to about 5%, or from about
2% to about 4%.  
  
[0132] A suitable foamer, by way of example, is the F2 Finger Pump
Foameracent made by AirSpray. Details of exemplary propellantless
defoamers are described in U.S. Pat. No. 5,443,569, issued on Aug.
22, 1995, and U.S. Pat. No. 5,813,576, issued Sep. 29, 1998,
herein incorporated by reference to the extent that it is
noncontradictory herewith.  
  
**Other Ingredients**  
  
[0133] Many other ingredients may be used in the formulation
provided they are not antagonistic to the intended function of the
product. Such ingredients may include chelating agents such as
EDTA, fragrances, viscosity modifiers, colors, opacifiers such as
titanium oxide, sensory agents such as menthol or other known
agents capable of producing a cooling or warming sensation on the
skin; essential oils, fatty acids, proteins including various
enzymes; probiotic agents to enhance growth of lactobaccili or
other desirable bacteria, and the like.  
  
[0134] Humectants and solubilizers may be used, such as butylene
glycol.  
  
[0135] In various embodiments, the formulation may be
substantially free of any or all of the following: ethanol,
methanol, propanol, alcohols, alcohols having 3 our fewer carbons,
alcohols having 2 or fewer carbons, glycolic acid, acetic acid,
critic acid, latex, spermicides, Octoxynol-9, TEA (triethylamine,
a compound which may contribute to unwanted odor) or derivatives
of TEA, TMA (trimethylamine), ammonia or complexes thereof,
amines, protein, polyhydroxy fatty acids, polyhydroxy acids,
alpha-hydroxy acids having 14 or greater carbons, fatty acids,
polyhydroxy fatty acid esters (or polyhydroxy fatty acid
derivatives such as esters, amides, and alcohols), benzoic acid,
preservatives, perfumes, artificial colors, sodium bicarbonate,
bicarbonates in solid or ionic form, retinol, or Retin-A.
aSubstantially freea in this context may mean lacking an effective
quantity. For alcohols and acids this may be taken as less than
0.1%. In some cases, the concentration may be less than 0.05%.
Xylitol or other 5-carbon sugars may be used to enhance the
antimicrobial benefits of the composition. See U.S. Pat. No.
7,619,008, issued Nov. 17, 2009 to Yang et al.  
  
[0136] The composition may be substantially free of aluminum,
aluminum salts, or other aluminum compounds, such as having less
than 1%, less than 0.5%, less than 0.1%, or less than 0.01% of
aluminum (e.g., aluminum ions). The composition may be
substantially free of zirconium, such as having less than 1%, less
than 0.5%, less than 0.1%, or less than 0.01% of zirconium (e.g.,
zirconium ions). In general, the composition may be substantially
free of effective amounts of aluminum and zirconium antiperspirant
compounds.  
  
[0137] U.S. Pat. No. 6,440,437, aWet Wipes Having Skin Health
Benefits,a issued Aug. 27, 2002 to Krzysik et al., herein
incorporated by reference to the extent that it is
noncontradictory herewith, describes a soft wet wipe or wipe-type
product, such as a baby wipe, an adult wipe, hand wipe, a face
wipe, a cosmetic wipe, a household wipe, an industrial wipe, a
personal cleansing wipe, cotton balls, cotton tipped swabs, and
the like, that can be made by combining the wipe or wipe-type
product with an oil-in-water emulsion composition comprising a
natural fat or oil, sterol or sterol derivative, humectant,
emulsifying surfactant, and water. Krzysik discuss a wet wipe or
wipe-type product with an oil-in-water emulsion composition
comprising a natural fat or oil, sterol or sterol derivative,
humectant, emulsifying surfactants and surfactant combinations
having an HLB range of about 7 to about 18, and water. The
composition is said to readily transfer from the wet wipe to the
skin to provide enhanced skin barrier benefits. The natural fat or
oil used in the composition may include borage oil, avocado oil,
or sunflower oil. The humectant used in the composition may
include glycerin, sorbitol, or propylene glycol. The emulsifying
surfactant used in the composition may include glyceryl stearate
SE, emulsifying wax NF, or propylene glycol oleate SE. The
composition may further comprise from about 0.1 to about 30% by
weight petrolatum or mineral oil.  
  
[0138] The lists of fats and oils, fatty acids, fatty alcohols,
essential oils, and emulsifying surfactants of Krzysik (U.S. Pat.
No. 6,440,437) are in particular incorporated herein by reference
and may be used for various embodiments herein.  
  
[0139] Suitable humectants may include, but are not limited to,
the following materials: acetamide MEA, Aloe Vera Gel, arginine
PCA, chitosan PCA, copper PCA, corn glycerides, dimethyl
imidazolidinone, fructose, glucamine, glucose, glucose glutamate,
glucuronic acid, glutamic acid, glycereth-7, glycereth-12,
glycereth-20, glycereth-26, glycerin, honey, hydrogenated honey,
hydrogenated starch hydrolysate, hydrolyzed corn starch, lactamide
MEA, lactic acid, lactose lysine PCA, mannitol, methyl gluceth-10,
methyl gluceth-20, PCA, PEG-2 lactamide, PEG-10 propylene glycol,
polyamino sugar condensate, potassium PCA, propylene glycol,
propylene glycol citrate, saccharide hydrolysate, saccharide
isomerate, sodium aspartate, socium lactate, sodium PCA, sorbitol,
TEA-Lactate, TEA-PCA, urea, xylitol, and the like, as well as
mixtures thereof.  
  
[0140] Non-ionic silicone surfactants may also be used, according
to US20070141127, aWet Wipes with Natural Antimicrobial Agents,a
herein incorporated by reference to the extent that it is
noncontradictory herewith. Suitable natural antimicrobial agents
discussed therein may also be used.  
  
[0141] U.S. Pat. No. 5,665,426 to Krzysik et al., herein
incorporated by reference to the extent that it is
noncontradictory herewith, describes a lotion formula that can be
applied to a tissue which will remain available for transfer to
the user's skin to reduce skin irritation and redness. The lotion
composition includes from about 30 to about 90% by weight of oil,
from about 10 to about 40% by weight wax, and from about 5 to
about 40% by weight of a fatty alcohol. The melting point of the
lotion composition is from about 30A deg C. to about 70A deg C. The
formulation was pre-melted at about 56A deg C. and the press supply
system (supply hose, doctor application head, and gravure roll)
was pre-heated to about 50A deg C. The deposit solidified almost
instantaneously on the surface of the treated tissue. Such a
system can be adapted for versions of the present system to apply
a lotion to a tissue, a wipe, a topsheet, or other suitable
surface for subsequent transfer to the skin of a user.  
  
[0142] In general, whether applied from a treatment on an
absorbent article, from a wipe of any kind, by a spray, sponge,
pads, by the fingers, or by any other means, the formulation may
have the characteristics of a semi-solid at both 20A deg C. and at 37A deg
C. (normal internal body temperature). For example, at 20A deg C., the
portion of the formulation that is liquid may be from about 2% to
about 60% by weight, or from about 5% to about 50% by weight, or
from about 5% to about 30% by weight. Upon heating to 37A deg C., the
liquid fraction may be from about 5% to about 80%, or from about
10% to about 75%, or from about 15% to about 70%, which may, for
example, represent an increase in the relative amount of liquid
present, wherein the ratio of the liquid weight percent at 37A deg C.
to the liquid weight percent at 20A deg C. may be greater than 1,
greater than 1.05, greater than 1.1, or greater than 1.2, such as
from 1.05 to about 20, from 1.05 to about 10, from 1.05 to 6, or
from 1.20 to 10.  
  
[0143] In one version, the formulation may have substantially
liquid properties at room temperature prior to being applied to a
substrate. U.S. Pat. No. 7,169,400, aWaterless Lotion and
Lotion-Treated Substrate,a issued Jan. 30, 2007 to Luu et al.,
herein incorporated by reference to the extent that it is
noncontradictory herewith, describes lotion compositions that are
substantially liquid at room temperature (defined by Luu et al. as
being from 20A deg C. to 25A deg C.) but which become semi-solid or
substantially more viscous after application to a substrate such
as a cellulosic or other polymeric web as a component of the
composition is absorbed by the substrate. In one version, Luu et
al. describe a lotion including a micro-emulsion, which comprises
a polar emollient, a non-polar emollient, a non-ionic surfactant,
and a co-surfactant wherein at least one of the emollients has
substantial solubility in either cellulosic or synthetic fiber.  
  
[0144] Non-polar emollients may include an aromatic or linear
ester, Guerbet ester, mineral oil, squalane, squalene, liquid
paraffin and the like. The polar or non-polar emollient is either
in the continuous outer phase or in the discontinuous internal
phase of the micro-emulsion. Non-ionic surfactants may include
PEG-20 methyl glucose sesquistearate, PPG-20 methyl glucose ether,
PPG-20 methyl glucose ether distearate, PEG-20 methyl glucose
distearate, PEG-120 methyl glucose dioleate, ethoxylated methyl
glucose having from about 10 to about 20 repeating ethoxy units,
and the like. The lotion may comprise, for example, at least 10A deg A
polyalkoxy or polyhydroxy emollient; an aromatic ester, such as
C12 to C15 alkyl benzoate ester or mineral oil; and may further
comprise myristyl alcohol and, for example, PEG-20 methylglucose
sesquistearate. Such lotions may be adapted for use with other
formulations described herein and may, for example, further
comprise mandelic acid.  
  
[0145] The formulation may also comprise a plurality of other
acidifying agents such as acetic acid, fumaric acid, ascorbic
acid, and the like. Known medicaments may also be included, such
as compositions in pharmaceutically effective concentrations for
treating infections, skin disorders, and other health conditions.  
  
**Packaging and Dispensing**  
  
[0146] Products made according to any of the embodiments of the
present invention may be packaged and/or dispensed in any known
way suitable for any particular product format. Wet wipes, for
example, may be packaged in perforated rolls contained within
flexible pouches or rigid dispensers of any kind. Wipes may also
be cut and folded into known configurations such as C-folds,
L-folds, M-folds, quarter folds, and the like, for dispensing
wipes from various known containers. In some embodiments, each
individual wet wipe is arranged in a folded configuration and
stacked one on top of the other to provide a stack of wet wipes.
The stack of folded wet wipes may be placed in the interior of a
container, such as a plastic tub, to provide a package of wet
wipes for eventual sale to the consumer. Alternatively, the wet
wipes may include a continuous strip of material which has
perforations between each wipe and which may be arranged in a
stack or wound into a roll for dispensing.  
  
[0147] Wipes or absorbent articles used within the scope of the
present invention may be packaged using any known wrapper, pouch,
casing, or other packaging system, such as those described in U.S.
Pat. No. 6,010,001, aIndividual Packaging for Hygienic Wiping,a
issued Jan. 4, 2000 to Osborn; U.S. Pat. No. 3,062,371,
aInternally Sterile Composite Package,a issued to D. Patience on
Nov. 6, 1962; U.S. Pat. No. 3,698,549, aPackages for Small
Articles,a issued to J. A. Glassman on Oct. 17, 1972; all of which
herein incorporated by reference to the extent that they are
noncontradictory herewith. Systems that may be adapted for use
with the present invention include U.S. Pat. No. 5,180,059, issued
Jan. 19, 1993, which describes packaging that protects the user's
hands during application.  
  
[0148] Wipes and other products may be provided in sterile heat
sealable pouches. Sterilization may be provided by gamma
irradiation, microwave radiation, e-beam radiation, ultraviolet
light, steam autoclaving, ethylene oxide treatment, etc. Pouches
may comprise foil, foil laminates, polymeric films, and the like.  
  
[0149] Wipes may also be dispensed from sealable jars such as
glass or plastic jars or other resilient containers. Any known dry
or wet wipe container may also be considered, including resilient
plastic tubs with openings for dispensing of wipes in a pop-up
manner, such as CottonelleA(r) wipes from Kimberly-Clark Corp.
(Dallas, Tex.).  
  
[0150] In one version, wipes may be co-packaged with single-use
dispensers of a formulation in the form of a lotion, cream, or
solution, wherein a cardboard or plastic container for wipes
(e.g., a rectangular container holding plurality of wipes) is
connected to a lid element by a hinge, in which the underside of
the lid contains a plurality of single-use formulation containers
such as pouches that can be opened by squeezing or tearing. The
single-use formulation containers may be held by a pocket on the
underside of the lid element, allowing them to be visible when the
lid element is placed in an upright or open position, allowing
both the wipes and the single-use containers to be visible and
readily selected and taken by a user, as desired.  
  
**Directions for Use**  
  
[0151] Inidicia placed on or otherwise associated with packaging
may inform users of the benefits of the product, call attention to
the relationship between fishy odor and the non-pathological
environment of the pudendum, provide information about the
importance of maintaining the right pH in that region, and give
instructions for use. Instructions for use may include, by way of
example, information similar to the following:  
  
[0152] aDirections for use. For best product performance, after
showering, blow dry your bottom on a low warm setting until skin
is dry. Apply the cream to the folds between your labia, up onto
your clitoral hood, perineum and between your buttocks including
the area around your anus.  
  
[0153] aFor best results, use the wipe to cleanse the areas of
your bottom after urination, bowel movements, intercourse and
rigorous activity. Reapply the cream if needed for added
protection especially after showering.a  
  
[0154] Indicia may be placed on the packaging material holding a
container of a composition such as an outer cardboard box, or may
be placed on the container that directly holds the composition
(e.g., a squeezable tube, a plastic or glass jar, a spray bottle,
a foam dispenser, a tube of wipes, etc.). Alternatively or in
addition, instructions for use may be associated with the product
in a variety of ways other that directly printing on a package.
The instructions may be provided on printed material that is
distributed with the product but physically detached therefrom, or
may be on a website or other information source that is associated
with the product (e.g., accessible via a QR code, barcode, RFID
tag, or URL printed on the package). Information about the product
and its use may also be approved in promotional media such as in
television commercials promoting the product. Such information may
point to the surprising discovery that many cases of fishy odor
are not due to pathological conditions in the vagina but are a
result of proximity of sources of anaerobic bacteria to the
pudendum coupled with pH lowering conditions, calling for care in
maintaining a suitable pH in the pudendum.  
  
[0155] Regions of the body likely to experience unwanted body odor
associated with perspiration include regions with apocrine sweat
glands such as the underarms region and the groin or pudendum, and
may also include other regions such as the chest, under the
breasts, the back, the feet, the scalp, and so forth. Such regions
may be identified in indicia (not shown) associated with various
products based on selected embodiments of the present invention.
Areas where body odor from sweat may be less likely include the
face or facial skin, the forearms, the hands (especially the back
of the hands), and the neck. In some embodiments, application of
the deodorant composition to the face may be specifically
proscribed (especially to skin near the eyes, nose, or mouth). The
same may apply for the back of the hands and the exposed neck.
Thus, indicia may indicate that the product should be used in the
underarm region or other regions likely to have body odor
associated with perspiration, and that the product should not be
used on the face or neck (or the head in general, if desired), or
on the hands.  
  
**Further Details**  
  
[0156] Caffeine or related xanthines may be provided as pure
substances, as phytoextracts, or in combination with other useful
ingredients, and then blended with other suitable ingredients for
the desired product form to give an antideodorant or
antiperspirant product. In some embodiments, the sweat inhibitory
effect of caffeine or related xanthines is enhanced with
antimicrobial benefits from carboxylic acids, particularly
alpha-hydroxy carboxylic acids such as mandelic acid.  
  
[0157] References to caffeine or any other xanthine are understood
to include salts thereof. Thus, caffeine citrate is understood to
fall within the scope of caffeine, although for purposes of
computing the weight percent of caffeine when a caffeine salt is
present, the mass of the salt should be normalize to the effective
mass of pure caffeine that would be present if the caffeine were
not in salt form. The same principle applies to other xanthines as
well.  
  
[0158] Formulation may be achieved by any known means for
preparing a composition of a desired format (e.g., cream, roll-on,
spray, etc.). This may include heating, agitating, homogenizing,
pressurized extrusion, and the like, with batch, continuous, or
semi-continuous processing all being within the scope of the
methods for various embodiments of the present invention.  
  
**EXAMPLES**  
  
**Example 1**  
  
[0159] A viscous cream comprising lactic acid, mandelic acid, and
an oil/water emulsion carrier was formulated using the following
ingredients:  
    Water  
 Lactic acid 8.0%  
 **Mandelic acid 4.0%**  
**Glycerin**  
**Xanthan gum thickener**  
**Polyquaternium 10**  
**Aloe vera extract**  
**Oat extract**  
**Allantoin**  
**Chamomile extract**  
**Sodium hydroxide**  
**Methylisothiazolinone (preservative)**  
**Capryl glycol**  
    
  The pH of the formulation was 4.0.  
  
[0160] This formulation was then tested with female subjects using
an external test agency. Seventeen product summaries were
collected from test subjects. The summaries are formatted on a 5
point scale with 5 being the most favorable to 1 being the least.
The product was evaluated on the properties as follows, texture,
feel after applied to the skin, irritability to the application
area, reduction or blocked odor, how well the women liked the
product and whether or not they would use the product again or
recommend it to a friend. Most of the women fell between the ages
of 20-50 with the exception on both extremes, the youngest being
nineteen and the oldest aged sixty-five. One women was pregnant in
her third trimester.  
  
[0161] Each of 5 parameters are separately considered. All 17 gave
the product a 5/5 rating in terms of texture and consistency.  
  
[0162] The product was not irritating to the area of application.
Thirteen of the 17 (76%). gave it a 5/5. Three of the 17 gave it a
4/5 or 18%. Combined 4-5/5 rating is 16/17 or 94%. One woman gave
it a 3/5 rating and then explained that she had stinging upon
initial application that went away quickly. She stated that
overall the product worked and she would buy the product and use
in the future. A point was made by several women that they had a
warming sensation upon initial application that they felt meant it
was working or one woman verbalized that it felt like K-Y warming
gel. None of the women felt that this was a negative. Some said
that they felt that it must be working.  
  
[0163] The product reduced or blocked odor. Thirteen of the 17
(76%) gave the product a 5/5 rating for odor reduction. Three of
the 17 gave a 4/5 or 18%. Combined rating of 4-5/5 is 16/17 or
94%. Of the women who gave a 4/5 in this category, there were no
additional comments about why they felt it was less than a 5. One
woman gave the product a 3/5. She said that it only made her feel
more wet and she did not like the product. Others stated that they
felt that the product helped with odor during menses, after
intercourse or after working out.  
  
[0164] For overall approval of the product, fourteen of the 17
(82%) gave it 5/5. One woman gave it a 4/5. Combined rating of
4-5/5 is 15/17 or 88%. One woman gave it a 2/5. (the one who did
not like the product because it made her feel more wet). The same
positive numbers were obtained when the subjects were asked if
they would use this product again and recommend it to others.  
  
**Example 2**  
  
[0165] Another version of a viscous cream was made with the
following ingredients:  
  
  **Water**  
**Lactic acid 10.0%**  
**Safflower oil**  
**Mandelic acid 2.0%**  
**Tricontyl PVP (water proofing agent)**  
**Glyceryl Stearate**  
**PEG-100 Stearate**  
**Emulsifing Wax**  
**Caprylic Capric Triglyceride**  
**Cetyl alcohol**  
**Dimethicone**  
**Polyacryamide**  
**C13 C14 Isoparaffin**  
**Laureth-7**  
**Aloe vera**  
**Allantoin**  
**Oat extract**  
**Chamomile extract**  
**Sodium Hydroxide**  
**Phenoxyrthanol (preservative)**  
**Chlorphenensin (preservative)**  
**Benzoic acid (preservative)**  
**Sorbic acid (preservative)**  
**Butylene Glycol**  
  
**Example 3**  
  
[0166] A composition for treating fishy odor arising from the
pudendum was prepared using the ingredients and weight percents
shown in Table 1:  
  
TABLE 1  
Ingredients in a composition for treating fishy odor.  
Sequence  INCI Names  Trade Names  % W/W 
Suppliers  
  
**1  Water  D.I. Water  49.60  Open**  
**1  Disodium EDTA  Versene Na2  0.100  Open**  
**1  Glycerin 99 vegetable  Glycerin 99 
5.00  Open**  
**1  Lactic Acid 70%  Purac  10.00  Purac
America**  
**1  DL Mandelic acid  Mandelic Acid  2.00 
Orient Star**  
**310/7016402**  
**1  Allantoin  Allantoin  0.10  Open**  
**2  Glyceryl Stearate & PEG  Arlacel 165 
3.50  Open**  
**100 Stearate**  
**2  Cetyl Alcohol  Cetyl Alcohol  2.00  Open**  
**2  Dimethicone  Dow Corning  1.00  Dow
Corning**  
**200/100**  
**2  Caprylic/Capric  Liponate CG  3.50  Lipo
chemical**  
**Triglyceride**  
**2  Emulsifying Wax  Polawax  3.00  Croda**  
**2  Tricontyl PVP  Ganez WP660  3.00  ISP**  
**2  Carthamus Tinctorius  High oleic  8.50 
Open**  
**(safflower) Seed Oil  Safflower oil**  
**3    Germazide PSB  1.00**  
**3  50% Sodium Hydroxide  Sodium  2.500 
Open**  
**Hydroxide**  
**3  Aloe Barbadensis leaf  Aloe 10 Fold 
0.50  Active organic**  
**extract**  
**3  Avena Sativa (oat) kernel  Oat extract 
0.10  a3**  
**extract**  
**3  Chamomilla Recutita  Chamomile  0.10  a3**  
**(Matricaria Matricaria)  extract**  
**flower extract**  
**4    Sepigel 305  2.50  Seppic**  
**4  PPG-12/SMDI Copolymer  Polyolperpolymer-2 
2.00  Barnet**  
  
**[0167] Procedures:**  
  
1. In a clean sanitized stainless steel tank, Sequence 1
ingredients were combined and mixed thoroughly to form a first
mixture.  
2. The first mixture was heated to 75A deg C. while mixing continued.  
3. In a separate stainless steel tank, Sequence 2 ingredients were
combined and heated to 75A deg C. to form a second mixture.  
4. After slight cooling, when both mixtures were at 70A deg C., the
second mixture was added gradually to the first mixture while
mixing. Mixing continued for another 15 minutes to form a third
mixture.  
5. A cooling cycle was then started as the third mixture was
cooled to 40A deg C. Then the Sequence 3 ingredients were added one at
time in the listed order while mixing to form a fourth mixture.  
6. The ingredients from Sequence 4 were then blended into the
fourth mixture to form the final composition.  
  
[0174] The final composition had a pH less than 4 and was then
tested for efficacy in terms of preventing malodor. Relative to
similar compositions without the PP-12 prepolymer (PPG-12), the
composition was found to be surprisingly effective in preventing
fishy odor from the pudendum, with a prolonged effect lasting over
24 hours. Without wishing to be bound by theory, it is believed
that the prepolymer compound assists in holding the alpha-hydroxy
acids of the composition off the skin and in an environment where
they can be effective in maintaining a low pH and reducing the
activity of anaerobic bacteria on the pudendum.  
  
[0175] The product apparently not only diminishes existing odor on
contact, but has a lasting effect that is believed to due at least
in part to the combination of alpha-hydroxy acids in a lipophilic
carriers. In a formulation without the prepolymer, the efficacy on
the pudendum was estimated to have a duration of about 6 to 8
hours, such that fishy odor was substantially reduced or prevented
after application, but would begin to return after about 8 hours.
With a change in formulation to include the prepolymer from
Barnet, the lasting odor control exceeded expectations and lasted
upwards of 24 hours. Another surprise was the observation of an
apparent cumulative effect with daily use over time, such that the
interval required before the return of malodor could be detected
increased significant over time beyond what was expected based on
experience with related formulations without the prepolymer. In
particular, the interval of time before the return of fishy odor
after activities like intercourse, menses, and exercise and
leaking urine was extended significantly and the intensity of the
fishy odor when it did return appeared to be significantly less
than expected as well. Without wishing to be bound by theory, it
may be that the bacterial load is well controlled on the pudendum
long after application of the product, and thus the amount of
aworka to be done by reapplication of the product is lessened with
regular use...  
  
**Example 7**  
  
[0199] A cream was formulated with a microsponge caffeine product
for controlled released. Multiple product batches were made with
the following target composition:  
  
**Mandelic acid 4-6%**  
**Caffeine powder 3.0% (CapsuDarA(r) Caffeine 85, a
microencapsulated caffeine powder coated with cellulose
derivative, marketed by LycoRed Bio Ltd. of Yavne, Israel).**  
**Corn starch**  
**Trichlosan**  
**PP2 2.0% (Barnet Products Group, Englewood Cliffs, N.J.)**  
**Aloe vera & chamomile**  
**Tea tree oil**  
**Other ingredients:**  
**Veg, glycerin**  
**Glyceryl stearate**  
**Cetyl alcohol**  
**Dimethicone**  
**Caprylic/Capric triglyceride**  
**Emulsifying wax**  
**Sodium hydroxide to PH 4.50**  
**Cucumber fragrance**  
  
[0216] The cream was tested on several human users, using manual
application to the underarm region and other areas as desired,
with excellent results in controlling odor and reducing
perspiration. Long-lasting odor control was observed, with several
users indicating that successful antiperspirant performance
increased initially as if the product performance was cumulative.
With a week of daily use, significant reduction on odor was
observed. Without wishing to be bound by theory, it may be that
the cumulative effect over time is to substantially reduce the
amount of odor-producing bacteria on the skin. The composition was
also found to be effective in keeping body odor out of clothing
also.  
  
[0217] Users of this and related compositions observed that the
skin felt smoother and was easier to shave, with less irritation.
Without wishing to be bound by theory, it is believed that the
alpha-hydroxy acids in this and related compositions act to smooth
the skin and to soften hair, allowing shaving with less
irritation.  
  
[0218] This formulation appeared to work best if applied when the
skin was dry...  
  
**Example 9**  
  
[0221] In a prophetic example, 1% or greater caffeine by weight or
other effective quantity of xanthine compounds are added to the
caffeine-free formulations of Examples 1 through 6 to create a
compound with the benefits of both xanthine compounds relative to
sweat reduction and alpha-hydroxy acids relative to odor
suppression. The product can then be formulated for application
via a sponge or wipe, or may be provided as a roll-on deodorant, a
spray-on deodorant, or a nonwoven or other absorbent pad that is
worn in contact with a region of the body suffering from malodor
such as the pudendum, wherein the absorbent pad that delivers an
effective amount of the formulation to the skin to reduce malodor
from perspiration...  
  


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