Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)
Trinity 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 eschar. 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 39% Cream 8 oz. (226.8g): NDC 54295-311-18 Store at room temperature 15°C - 30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Marketed by: Trinity Pharma LLC 2255 Glades Road Suite 324A Boca Raton, FL 33431 TrinityPharmaLLC.com
unapproved drug other
UREA - UREA CREAM TRINITY 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 39% Rx Only For external use only. Not for ophthalmic use. DESCRIPTION Urea Cream 39% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea Cream 39% contains 39% urea as an active ingredient, and the following inactive ingredients: Water, Propylene Glycol, Glyceryl Stearate, Mineral Oil, Cetyl Alcohol, Carbomer, Petrolatum, Xanthan Gum and Sodium Hydroxide. 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 eschar. 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. PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, Przeczytaj cały dokument