Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)
Laser Pharmaceuticals, LLC
TOPICAL
PRESCRIPTION DRUG
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. Known hypersensitivity to any of the listed ingredients.
Urea 40% Cream 1 oz.(28.35 g): NDC 16477-340-01; Urea 40% Cream 3 oz.(85 g): NDC 16477-340-03; Urea 40% Cream 7 oz.(198.4 g): NDC 16477-340-07 Store at room temperature 15°C - 30°C (59°F - 86°F). Protect from freezing. Keep bottle tightly closed.
unapproved drug other
UREA CREAM 40%- UREA CREAM LASER PHARMACEUTICALS, LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- UREA CREAM 40% UREA CREAM 40% Rx Only For external use only. Not for ophthalmic use. DESCRIPTION Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40% contains 40% 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: 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. PHARMACOKINETICS The mechanism of action of topically applied urea is not yet known. 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. CONTRAINDICATIONS Known hypersensitivity to any of the listed ingredients. WARNINGS For topical use only. Avoid contact with eyes, lips or mucous membranes. 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. PREGNANACY Pregnancy Category B. Animal reproduction studies have revealed no evidence of ha Przeczytaj cały dokument