DailyMed Label: CEM-Urea

DailyMed Label: CEM-Urea

2011

DailyMed Prescription

CEM-Urea

urea

PruGen, Inc.

NDC: 42546-100

NDC: 42546-100

CEM-UreaTM (45% Urea) is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of CEM-UreaTM (45% Urea) contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, methyl paraben, propylene glycol and purified water. Urea is a diamide of carbonic acid with the following chemical structure:

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, devitalized and ingrown nails.

DIRECTIONS FOR NAILS: Apply CEM-UreaTM (45% Urea) to diseased or damaged nail tissue twice per day, or as directed by a physician. DIRECTIONS FOR SKIN: Apply CEM-UreaTM (45% Urea) to affected area(s) twice per day, or as directed by a physician.

Known hypersensitivity to any of the listed ingredients.

For external use only. Avoid contact with eyes, lips or mucous membranes. 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.

Transient stinging, burning, itching or irritation may occur and normally disappear

CEM-UreaTM (45% Urea) 20 mL tube, NDC 42546-100-20

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.

NDC 42546-100-20 CEM-Urea Pre-Filled Applicator 45% urea In a vehicle containing Menthol, Camphor, and Eucalyptus Oil Rx only 0.68 FL OZ (20 mL) PruGen, Inc. Pharmaceuticals image of tube label