a pretty big X-Viate Generic Name: urea Dosage Form: cream, lotion, gel Overview Side Effects Dosage Professional Reviews More Support Group Q & A Pricing & Coupons 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. X-Viate 40% CREAM (Urea 40% in a cream base) X-Viate 40% LOTION (Urea 40% in a lotion base) X-Viate 40% GEL (Urea 40% in a gel base) Rx only For external use only. Not for ophthalmic use. Slideshow Seasoned Pro: Be Mindful of These Winter Health Hazards X-Viate Description X-Viate is a potent keratolytic emollient which is a gentle tissue softener for skin and/or nails. Each gram of X-Viate 40% CREAM contains 40% Urea in a cream base of Carbopol, Cetyl Alcohol, Glyceryl Monostearate, Light Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, White Petrolatum and Xanthan Gum. Each gram of X-Viate 40% LOTION contains 40% Urea in a lotion base of Carbopol, Cetyl Alcohol, Glyceryl Stearate, Methyl Paraben, Mineral Oil, Propyl Paraben, Propylene Glycol, Purified Water, Trolamine, White Petrolatum and Xanthan Gum. Each gram of X-Viate 40% GEL contains 40% Urea in a gel base of Hydroxyethyl Cellulose, Methyl Paraben, Propylene Glycol and Purified Water. CHEMISTRY Urea is a diamide of carbonic acid with the following chemical structure: X-Viate - 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. 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. PHARMACOKINETICS The mechanism of action of topically applied Urea is not yet known. 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. Contraindications Known hypersensitivity to any of the listed ingredients. Warnings For external use only. Avoid contact with eyes, lips or mucous membranes. Precautions 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 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, X-Viate should be given to a pregnant woman only if clearly needed. NURSING MOTHERS It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when X-Viate is administered to a nursing woman Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication. X-Viate Dosage and Administration Apply X-Viate 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. How is X-Viate Supplied X-Viate 40% CREAM (40% Urea) is supplied in: 28.5g (1 oz) tube 58980-625-10 85g (3 oz) tube 58980-625-30 199g (7 oz) tube 58980-625-70 X-Viate 40% LOTION (40% Urea) is supplied in: 237mL (8 oz) bottle 58980-623-80 X-Viate 40% GEL (40% Urea) is supplied in: 15mL bottle 58980-624-15 Store at controlled room temperature 15 -30 C (59 -86 F). Protect from freezing. Distributed by: Stratus Pharmaceuticals Inc, Miami, Florida 33186-6727 Tollfree: 800-442-7882 www.stratuspharmaceuticals.com Manufactured by: Sonar Products, Inc., Carlstadt, NJ 07072 PG-XVG-IN 2009-0608 PRINCIPAL DISPLAY PANEL - 199g Tube Carton X-Viate 40% CREAM NDC 58980-625-70 X-Viate 40% CREAM Softens and Moisturizes Severe Dry Skin Rx only UREA 40% IN A CREAM BASE Distributed by: STRATUS PHARMACEUTICALS INC NET WT 7 oz (199g) X VIATE urea cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-625 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Urea (Urea) Urea 0.4 g in 1 g Inactive Ingredients Ingredient Name Strength Cetyl Alcohol Glyceryl Monostearate Light Mineral Oil Propylene Glycol Water Sodium Hydroxide Petrolatum Xanthan Gum Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:58980-625-10 1 TUBE (TUBE) in 1 BOX 1 28.3 g in 1 TUBE 2 NDC:58980-625-30 1 TUBE (TUBE) in 1 BOX 2 85 g in 1 TUBE 3 NDC:58980-625-70 1 TUBE (TUBE) in 1 BOX 3 199 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/11/2005 Labeler - Stratus Pharamceuticals, Inc (789001641) Registrant - Sonar Products, Inc (104283945) Establishment Name Address ID/FEI Operations Sonar Products, Inc 104283945 MANUFACTURE Revised: 10/2010 Stratus Pharamceuticals, Inc Next User Reviews Print this page Add to My Med List More about X-Viate (urea topical) Side Effects Dosage Information Support Group Pricing & Coupons En Español 5 Reviews Add your own review/rating Drug class: topical emollients Consumer resources X-Viate Professional resources X-Viate Gel (FDA) X-Viate Lotion (FDA) Other brands: Latrix , Rea Lo 40 , Keralac , Remeven , ... +22 more Related treatment guides Pityriasis rubra pilaris Dermatological Disorders Dry Skin FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical emollients Related Drugs topical emollients Lac-Hydrin , Eucerin , ammonium lactate topical , glycerin topical , AmLactin , Aquaphor Dry Skin Lac-Hydrin , Eucerin , ammonium lactate topical , AmLactin , Aquaphor , urea topical , CeraVe , Cetaphil Lotion , More... Dermatological Disorders triamcinolone , clobetasol topical , betamethasone , Temovate , Diprolene , Analpram-HC , Celestone , More... Pityriasis rubra pilaris urea topical , Carmol , Latrix , Keralac , Remeven , More... X-Viate Rating 5 User Reviews 9.6 /10 5 User Reviews 9.6 Rate it! extensive
years to come X-Viate is consider
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