DailyMed Label: UREA HYDRATING TOPICAL

DailyMed Label: UREA HYDRATING TOPICAL

2024

DailyMed Prescription

UREA HYDRATING TOPICAL

UREA

Acella Pharmaceuticals

NDC: 42192-115

NDC: 42192-115

NDC: 42192-115

DESCRIPTION Urea 35% Hydrating Topical Foam is a keratolytic emollient in a water and lipid based foam containing lactic acid which is a 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

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.

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

CONTRAINDICATIONS Known hypersensitivity to any of the listed ingredients.

PRECAUTIONS Urea 35% Hydrating Topical Foam should be used only as directed by a 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 a prescribing physician.

ADVERSE REACTIONS

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

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

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