País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)
Bryant Ranch Prepack
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. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
7 oz. (198.4 g) bottles, NDC 72162-2192-2 3 oz. (85 g) bottles, NDC 72162-2192-4 1 oz. (28.35 g) bottles, NDC 72162-2192-7 To report a serious adverse event or obtain product information, call (866) 762-2365. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
unapproved drug other
UREA- UREA CREAM BRYANT RANCH PREPACK _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 40% CREAM RX ONLY FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION: Each gram contains 400 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure: CLINICAL PHARMACOLOGY: 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 of the skin. PHARMACOKINETICS:The mechanism of action of topically applied urea is not yet known. INDICATIONS: 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: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. WARNING: KEEP OUT OF REACH OF CHILDREN. PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. GENERAL:This product 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. INFORMATION FOR PATIENTS:Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact Leia o documento completo