DESCRIPTION SECTION.

DESCRIPTION: Each gram of 50% Urea Emulsion contains 50% urea in formulation consisting of: caprylic/capric triglyceride, cetyl alcohol, disodium EDTA, glycerin, hydroxyethyl cellulose, lactic acid, linoleic acid, PEG-6, polysorbate 60, propylene glycol, sorbitan stearate, titanium dioxide, triethanolamine, purified water, vitamin E, xanthan gum and zinc undecylenate. Urea is diamide of carbonic acid with the following chemical structure:. urea chemical formula.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION: Apply 50% Urea Emulsion to affected skin twice per day, or as directed by physician. Rub in until completely absorbed.

HOW SUPPLIED SECTION.

HOW SUPPLIED: 50% Urea Emulsion is supplied in 10 oz. tube (NDC 42192-101-10). Store at controlled room temperature, 15 30 (59 86F). Protect from freezing.

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 pilaris, keratosis palmaris, keratoderma, corns and calluses.

NURSING MOTHERS SECTION.

NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 50% Urea Emulsion is administered to nursing woman.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

NDC 42192-101-10 50% Urea Emulsion In zinc undecylenate and lactic acid vehicle Rx Only Net Weight 10 oz For Topical Use Only Indications: For use on rough dry skin conditions. See carton or package insert for instructions. USE ONLY AS DIRECTED BY PHYSICIAN. Ingredients: Each gram of 50% Urea Emulsion contains 50% urea in formulation consisting of caprylic or capric triglyceride, cetyl alcohol, disodium EDTA, glycerin, hydroxyethyl cellulose, lactic acid, linoleic acid, PEG-6, polysorbate 60, propylene glycol, sorbitan stearate, titanium dioxide, triethanolamine, purified water, vitamin E, xanthan gum and zinc undecylenate. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Storage: Store at controlled room temperature 15 30C (59 86F) Protect from freezing. For lot number and expiration date, see crimp of tube. All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Note: This is not an Orange Book product. Please see insert for further details. Manufactured for: Acella Pharmaceuticals 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802.

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: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, 50% Urea Emulsion should be given to pregnant woman only if clearly needed.