{"active_ingredient":["Active Ingredient Urea 10%"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply to the affected areas twice a day or as directed by a physician. Rub into the skin until completely absorbed. Store at 25°C (77°F); excursion permitted to 15°C - 30°C (59° - 86°F). Protect from Freezing. [See USP Controlled Room Temperature]. Protect from Freezing. See bottom of box and/or bottle for lot number and expiration date. SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION."],"effective_time":"20171026","id":"a01a29d2-401b-49ca-b2ff-8e64a5b33705","inactive_ingredient":["Inactive Ingredients Carbomer, Fragrance, Isopropyl Myristate, Isopropyl Palmitate, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearic Acid, Trolamine and Xanthan Gum."],"indications_and_usage":["Keratolytic"],"keep_out_of_reach_of_children":["Precautions Stop use and ask a doctor if redness or irritation develops. Keep this and all other medications out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 466.7g Bottle Carton NDC 58980-608-90 UREA 10% LOTION Softens and Moisturizes Severe Dry Skin Distributed by: STRATUS PHARMACEUTICALS INC Net WT. 16 Fl oz PRINCIPAL DISPLAY PANEL - 466.7g Bottle Carton"],"pregnancy":["Pregnancy If pregnant or breast feeding, ask a health professional before use."],"purpose":["Purpose Keratolytic"],"set_id":"eec3162d-db41-4f40-8b0c-a61ef05469af","spl_product_data_elements":["Urea Urea Urea Urea CARBOXYPOLYMETHYLENE"],"spl_unclassified_section":["Drug Facts","Manufactured for: Stratus Pharmaceuticals Inc. 12379 SW 130th Street Miami, Florida 33186 Manufactured by: Sonar Products Inc Carlstadt, NJ 07072"],"storage_and_handling":["Directions DOSAGE AND ADMINISTRATION Apply to the affected areas twice a day or as directed by a physician. Rub into the skin until completely absorbed. Store at 25°C (77°F); excursion permitted to 15°C - 30°C (59° - 86°F). Protect from Freezing. [See USP Controlled Room Temperature]. Protect from Freezing. See bottom of box and/or bottle for lot number and expiration date. SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION."],"version":"2","warnings":["Warnings FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin. Do not use if known hypersensitivity to any of the listed ingredients. Precautions Stop use and ask a doctor if redness or irritation develops. Keep this and all other medications out of 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."]}