[Merz Pharmaceuticals, LLC]
|Category||DEA Schedule||Marketing Status|
|HUMAN PRESCRIPTION DRUG LABEL||unapproved drug other|
Aluvea™ (urea) cream, 39% is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin.
Each gram of Aluvea Cream contains 39% Urea as the active ingredient, and the following inactive ingredients: dimethyl isosorbide, emulsifying wax NF, glycerin 99.7% USP, isopropyl myristate, purified water, sorbitol 70% Solution USP, tridecyl stearate and neopentyl glycol dicaprylate/dicaprate and tridecyl trimellitate.
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.
INDICATION AND USAGE
Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.
Urea should be used as directed by a physician and should not be used to treat conditions other than those for which it was prescribed. If redness or irritation occurs, discontinue use.
Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication.
DOSAGE AND ADMINISTRATIONS
Apply Aluvea to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.
Aluvea is supplied in an 8oz. bottle.
|Labeler - Merz Pharmaceuticals, LLC (126209282)|
|Crown Laboratories, Inc.||079035945||MANUFACTURE|