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UMECTA MOUSSE UREA 40%
urea aerosol, foam
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
----------Umecta Mousse PI
For topical use only
Not for ophthalmic use
Umecta is a keratolytic, emollient which is a gentle, yet potent, tissue softener for nails and skin
Each gram of Umecta mousse contains urea (40%), Butane, Butyrospermum Parkii
(Shea Butter) Extract, Carbomer, Glycine Soya (Soy Bean) Sterol, Helianthus Annuus
(Sunflower) Oil, Isobutane, Laureth-4, Polysorbate-20, Propane, Purified Water,
Stearic Acid, Triethanolamine. Urea is a diamide of carbonic acid with the
following chemical structure:
Urea gently dissolves the intercellular matrix which results in loosening the horny layer of
skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates
and gently dissolves the intercellular matrix of the nail plate which can result in the softening and eventual debridement
of the nail plate.
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly
For external use only. Avoid contact with eyes, lips or mucous membranes.
Umecta Mousse canister - contents under pressure do not puncture or
This medication is to be used as directed by a physician and should not be used to treat any
condition other than that for which it was prescribed. If redness or irritation occurs,
Animal reproduction studies have not been conducted with Umecta. It is also not known
whether Umecta can cause fetal harm when administered to a pregnant woman
or can affect reproductive capacity. Umecta should be given to a pregnant
woman only if clearly needed.
It is not known whether or not this drug is secreted in human milk. Because many drugs are
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Transient stinging, burning, itching, or irritation may occur and normally disappear on discontinuing
Apply Umecta PD bioadhesive emulsion/topical suspension or Umecta
Umecta (urea, 40%) mousse is available in a:
4 oz. can NDC 68712-020-01
Store at controlled room temperature 15-30°C (59-86°F).
Protect from freezing.
Revised: 08/2009 JSJ Pharmaceuticals
Reproduced with permission of U.S. National Library of Medicine
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