{"active_ingredient":["Active Ingredient: UREA 20%"],"do_not_use":["Do not use: Do not use if safety seal on the tube is broken or missing. For lot number and exp. date, see crimp of tube or carton."],"dosage_and_administration":[""],"effective_time":"20260112","id":"48379414-bcb9-1797-e063-6394a90aa8fd","inactive_ingredient":["Inactive Ingredients : Cetyl Alcohol, Carbomer, Glycerin, Glyceryl Stearate SE, Mineral Oil, Purified Water, Stearyl Alcohol, Triacetin, White Petrolatum."],"indications_and_usage":["Usage: Soothes, Softens and Moisturizes Dry Rough Skin."],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN. For External Use Only."],"openfda":{"brand_name":["Urea 20"],"generic_name":["UREA"],"is_original_packager":[true],"manufacturer_name":["AvPAK"],"package_ndc":["50268-820-85"],"product_ndc":["50268-820"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["48379414-bcb9-1797-e063-6394a90aa8fd"],"spl_set_id":["e994fa05-a457-2555-e053-2a95a90ae83b"],"substance_name":["UREA"],"unii":["8W8T17847W"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL UREA 20% Cream FOR EXTERNAL USE ONLY. Soothes, Softens and Moisturizes Dry Rough Skin AvKARE NET WT. 3 OZ. (85 g) Manufactured for: AvKARE, Pulaski, TN 38478 www.avkare.com Questions or comments? 1-855-361-3993 AV 04/22 UREA 20% Cream Product No. 50268-820-85 FOR EXTERNAL USE ONLY. Soothes, Softens and Moisturizes Dry Rough Skin AvKARE NET WT. 3 OZ. (85 g) Carton tube"],"purpose":["Purpose : Moisturizer"],"questions":["Questions or comments? 1-855-361-3993"],"set_id":"e994fa05-a457-2555-e053-2a95a90ae83b","spl_product_data_elements":["Urea 20 Urea CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETYL ALCOHOL GLYCERIN GLYCERYL STEARATE SE MINERAL OIL WATER STEARYL ALCOHOL TRIACETIN WHITE PETROLATUM UREA UREA Opaque White"],"stop_use":["Stop use: Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes."],"storage_and_handling":["Storage: Store at 20°C (68°F - 77°F), excursions permitted between 15°C and 30°C (59°F - 86°F). Protect from Freezing. Store in a cool dry place. [See USP Controlled Room Temperature]"],"version":"4","warnings":["WARNINGS SECTION Caution: Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes."],"when_using":["Directions: Apply to desired areas of the hands, feet, knees, or elbows twice daily, or as directed by a physician. Rub into the skin until fully absorbed. Do not use on tender skin areas such as the face, neck, or scalp."]}