DailyMed Label: Urea Cream 41%

DailyMed Label: Urea Cream 41%

2023

DailyMed Prescription

Urea Cream 41%

Urea

Laser Pharmaceuticals, LLC

NDC: 16477-341

NDC: 16477-341

Description Urea 41% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 41% contains 41% urea as an active ingredient, and the following inactive ingredients: Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Xanthan Gum. Urea is a diamide of carbonic acid with the following chemical structure: image description

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 eshar. 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, as well as damaged, ingrown and devitalized nails.

Dosage and Administration Apply Urea 41% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each person's professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.

Contraindications Known hypersensitivity to any of the listed ingredients.

Urea Cream 41% Rx Only     For external use only.     Not for ophthalmic use.

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 and consult a physician.

How Supplied Urea 41% Cream 8 oz.(227 g): NDC 16477-341-08 Store at room temperature 15°C - 30°C (59°F - 86°F). Protect from freezing. Keep bottle tightly closed.

Clinical Pharmacology Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.

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