ADVERSE REACTIONS SECTION.

Adverse Reactions. Transient stinging, burning, itching, or irritation may occur and normally disappear on discontinuing the medication.

CLINICAL PHARMACOLOGY SECTION.

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.

CONTRAINDICATIONS SECTION.

Contraindications. Known hypersensitivity to any of the listed ingredients.

DESCRIPTION SECTION.

Description. Rx onlyFor topical use onlyNot for ophthalmic useUmecta is keratolytic, emollient which is 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 diamide of carbonic acid with the following chemical structure:. Image of chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

Dosage and Administration. Apply Umecta PD bioadhesive emulsion/topical suspension or Umecta mousse to affected skin twice per day, or as directed by physician. Rub in until completely absorbed.

HOW SUPPLIED SECTION.

How Supplied. Umecta (urea, 40%) mousse is available in a: oz. can NDC 68712-020-01Store at controlled room temperature 15-30C (59-86F).Protect from freezing.Manufactured for:Innocutis Holdings LLCCharleston, SC 29401 Toll Free: 1-800-499-4468www.innocutis.comwww.umecta.com.

INDICATIONS & USAGE SECTION.

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.

NURSING MOTHERS SECTION.

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 nursing woman.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

PHARMACOKINETICS SECTION.

Pharmacokinetics. The mechanism of action of topically applied urea is not yet known.

PRECAUTIONS SECTION.

Precautions. This medication is to be used as directed by 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 SECTION.

Pregnancy. Animal reproduction studies have not been conducted with Umecta. It is also not known whether Umecta can cause fetal harm when administered to pregnant woman or can affect reproductive capacity. Umecta should be given to pregnant woman only if clearly needed.

WARNINGS SECTION.

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 120o F.