PRECAUTIONS SECTION.

PRECAUTIONS Urea 35% Hydrating Topical Foam should be used only as directed by physician and should not be used to treat any condition other than that for which it is prescribed. If redness or irritation occurs, discontinue use and consult with prescribing physician.

PREGNANCY SECTION.

Pregnancy (Category B) Animal reproduction studies have not been performed with topically applied urea and it is not known whether Urea 35% Hydrating Topical Foam can cause fetal harm when administered to pregnant woman. Nevertheless, Urea 35% Hydrating Topical Foam should be used by pregnant woman only if necessary.

SPL UNCLASSIFIED SECTION.

Enter section text here.

WARNINGS SECTION.

WARNINGS Urea 35% Hydrating Topical Foam is for external use only. It is not for ophthalmic, oral, anal or intravaginal use. Contact with eyes, lips, and all mucous membranes should be avoided. Urea 35% Hydrating Topical Foam should not be used by persons who have known hypersensitivity to urea or any of the other listed ingredients.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS Transient stinging, burning, itching or irritation is possible.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY Topically applied urea dissolves the intercellular matrix of the skin which results in enhanced shedding of scaly, dry skin and thus softening of the hyperkeratotic areas of the skin. Urea topically applied to the nail plate has similar effect on the intercellular matrix of the nail plate.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS Known hypersensitivity to any of the listed ingredients.

DESCRIPTION SECTION.

DESCRIPTION Urea 35% Hydrating Topical Foam is keratolytic emollient in water and lipid based foam containing lactic acid which is gentle, but potent, tissue softener for skin and nails. Each gram of Urea 35% Hydrating Topical Foam contains Urea 35% as the active ingredient, and the following inactive ingredients: dimethicone, ethylparaben, glycerin, lactic acid, methylparaben, phenoxyethanol, polysorbate 20, povidone, propylene glycol, propylparaben, purified water, stearic acid, trolamine, and in propellants butane and propane. CHEMICAL STRUCTURE Urea has the following chemical structure: ureachemformula.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION Unless otherwise directed by prescribing physician, Urea 35% Hydrating Topical Foam should be applied to affected area twice day. Urea 35% Hydrating Topical Foam should be rubbed into the skin until it is completely absorbed.

HOW SUPPLIED SECTION.

HOW SUPPLIED Urea 35% Hydrating Topical Foam is supplied in 150 gram or 5.3 ounce aerosolized canister bearing the NDC Number 42192-115-15.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE For enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris, or eschar. Topically applied urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, and dry, rough skin, as well as corns and calluses and damaged, ingrown and devitalized nails.

NURSING MOTHERS SECTION.

Nursing Mothers It is not known whether topically applied urea is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering Urea 35% Hydrating Topical Foam to nursing mothers.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

productlabel.

PHARMACOKINETICS SECTION.

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