{"adverse_reactions":["ADVERSE REACTIONS Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication."],"clinical_pharmacology":["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."],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to any of the listed ingredients."],"description":["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: Chemical Structure"],"dosage_and_administration":["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."],"effective_time":"20171128","how_supplied":["HOW 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."],"how_supplied_table":["
28.5g (1 oz) tube 58980-625-10
85g (3 oz) tube 58980-625-30
199g (7 oz) tube 58980-625-70
","
237mL (8 oz) bottle 58980-623-80
","
15mL bottle 58980-624-15
"],"id":"6b7a34a1-c288-4f61-9538-e4b8b6f8129c","indications_and_usage":["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."],"nursing_mothers":["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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton X-VIATE 40% GEL NDC 58980-624-15 X-VIATE™ 40% GEL Gentle, potent, tissue softener, for nail and skin Rx only UREA 40% IN A GEL BASE Distributed by STRATUS NET WT 15 mL Bottle with Applicator Brush PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton"],"pharmacokinetics":["PHARMACOKINETICS The mechanism of action of topically applied Urea is not yet known."],"precautions":["PRECAUTIONS If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroug hly. 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."],"pregnancy":["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."],"set_id":"aaaa2a9e-5865-448f-90eb-0101aaddd75c","spl_product_data_elements":["X-Viate Urea Urea Urea POLYETHYLENE GLYCOL 400 Methylparaben Water"],"spl_unclassified_section":["Rx only For external use only. Not for ophthalmic use.","Distributed by: Stratus Pharmaceuticals Inc, Miami, Florida 33186-6727 Toll free: 800-442-7882 www.stratuspharmaceuticals.com Manufactured by: Sonar Products, Inc., Carlstadt, NJ 07072 PG-KVG-IN 2009-0608"],"storage_and_handling":["Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing."],"teratogenic_effects":["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."],"version":"2","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips or mucous membranes."]}