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® emulsion and topical suspension contains 40% urea, butylated hydroxytoluene, butyrospermum parkii fruit oil, disodium EDTA, glyceryl stearate, glycine soja sterol, helianthus annuus oil, purified water, stearic acid, sodium polyacrylate, and triethanolamine.

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 Uses

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.

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 Category C

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 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%) emulsion/topical suspension supplied in a:

4 oz. plastic tube (emulsion)
NDC 68712-004-03

8 oz. plastic tube (emulsion)
NDC 68712-004-01
Manufactured for:
Innocutis Holdings LLC
Charleston, SC 29401
Toll Free: 1-800-499-4468
www.innocutis.com
www.umecta.com