FDA Label for Umecta Mousse Urea
View Indications, Usage & Precautions
Umecta Mousse Urea Product Label
The following document was submitted to the FDA by the labeler of this product Epi Health, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Rx only
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:
Clinical Pharmacology
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.
Pharmacokinetics
The mechanism of action of topically applied urea is not yet known.
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.
Contraindications
Known hypersensitivity to any of the listed ingredients.
Warnings
For external use only. Avoid contact with eyes, lips or mucous membranes. Umecta Mousse canister - contents under pressure do not puncture or incinerate. Do not store at temperatures above 120° F.
Precautions
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, discontinue use.
Pregnancy
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.
Nursing Monthers
It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Umecta is administered to a nursing woman.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Adverse Reactions
Transient stinging, burning, itching, or irritation may occur and normally disappear on discontinuing the medication.
Dosage And Administration
Apply Umecta PD bioadhesive emulsion/topical suspension or Umecta mousse to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed
How Supplied
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.
Manufactured for:
Innocutis Holdings LLC
Charleston, SC 29401
Toll Free: 1-800-499-4468
www.innocutis.com
www.umecta.com
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