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(Urea 50% in a cream base)
REMEVEN™ CREAM is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails.
Each gram of REMEVEN™ CREAM contains:
ACTIVE: 50% Urea in a cream base of:
INACTIVES:Acrylates Copolymer, Carbomer, dl - Alphatocopheryl Acetate, Disodium EDTA, Glycerine, Lactic Acid, Mineral Oil, Polysorbate 85, Purified Water, Sodium Hydroxide, Stearic Acid and Zinc Pyrithione.
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.
INDICATIONS AND USES
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or prurient 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, ingrown and devitalized nails.
If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
Pregnancy Category B
Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, REMEVEN™ CREAM should be given to a pregnant woman only if clearly needed.
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
DOSAGE AND ADMINISTRATION
Apply REMEVEN™ CREAM to affected skin twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day or as directed by a physician.
REMEVEN™ CREAM (50% Urea) is supplied in:
PRINCIPAL DISPLAY PANEL - 142 g Carton
Revised: 05/2011 Stratus Pharmaceuticals, Inc
Reproduced with permission of U.S. National Library of Medicine
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