Label: UMECTA MOUSSE UREA- urea foam aerosol, foam
- NDC Code(s): 71403-020-01
- Packager: EPI Health, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Updated December 27, 2017
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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.
Indications and Usage
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns, and calluses, as well as damaged, ingrown and devitalized nails.
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- Adverse Reactions
- Dosage and Administration
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- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
UMECTA MOUSSE UREA
urea foam aerosol, foam
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71403-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 400 mg in 1 g Inactive Ingredients Ingredient Name Strength BUTANE (UNII: 6LV4FOR43R) SHEA BUTTER (UNII: K49155WL9Y) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) SOYBEAN OIL (UNII: 241ATL177A) SUNFLOWER OIL (UNII: 3W1JG795YI) ISOBUTANE (UNII: BXR49TP611) LAURETH-4 (UNII: 6HQ855798J) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPANE (UNII: T75W9911L6) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71403-020-01 113.4 g in 1 CAN; Type 0: Not a Combination Product 09/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/01/2007 Labeler - EPI Health, Inc (080638894) Establishment Name Address ID/FEI Business Operations EPI Health, Inc 080638894 manufacture(71403-020)