{"dosage_and_administration":["Directions Apply to the affected skin twice per day, or as directed by a physician. Rub in until completely absorbed."],"effective_time":"20171129","how_supplied":["Other Information Store at controlled room temperature 15°-30°C (59°-86°F) Protect from freezing."],"id":"0175653b-bdad-4b44-bdd8-8ec9feb20a45","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 8.0 fl. oz. Label NDC 58980-623-80 X-VIATE™ 40 % LOTION Softens and Moisturizes Severe Dry Skin Rx only UREA 40% IN A LOTION BASE Distributed by: STRATUS PHARMACEUTICALS INC 8.0 fl. oz. (237 mL) Principal Display Panel - 8.0 fl. oz. Label","PRINCIPAL DISPLAY PANEL - 8.0 fl. oz. Box NDC 58980-623-80 X-VIATE™ 40 % LOTION Softens and Moisturizes Severe Dry Skin Rx only UREA 40% IN A LOTION BASE Distributed by: STRATUS PHARMACEUTICALS INC 8.0 fl. oz. (237 mL) Principal Display Panel - 8.0 fl. oz. Box"],"precautions":["Precautions Stop use and ask a doctor if redness or irritation develops. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Pregnancy If pregnant or breast feeding, ask a health professional before use."],"pregnancy":["Pregnancy If pregnant or breast feeding, ask a health professional before use."],"set_id":"f45dfdfa-9b25-494a-b558-656168c27b07","spl_product_data_elements":["X Viate Urea Urea Urea"],"spl_unclassified_section":["Drug Facts","Active Ingredient Urea 40%","Purpose Keratolytic Agent","Inactive Ingredients Carbopol, Cetyl Alcohol, Glyceryl Stearate, Methyl Paraben, Mineral Oil, Propyl Paraben, Propylene Glycol, Purified Water, Trolamine, White Petrolatum and Xanthan Gum.","Manufactured by: Sonar Products, Inc. Carlstadt, New Jersey 07072 Exclusively for: Stratus Pharmaceuticals Inc 12379 Southwest 130th Street Miami, FL 33186"],"storage_and_handling":["Other Information Store at controlled room temperature 15°-30°C (59°-86°F) Protect from freezing."],"version":"2","warnings":["Warnings For external use only. Avoid contact with eyes, lips, or mucous membranes. Do not use: On areas of broken skin If known hypersensitivity to any of the listed ingredients."]}