{"active_ingredient":["Active ingredient Zinc oxide (15.29%)"],"dosage_and_administration":["Directions Apply as needed For diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow it to dry. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged."],"effective_time":"20240829","id":"20d2cf0b-d236-fd78-e063-6394a90a8d03","inactive_ingredient":["Inactive ingredients beeswax, benzyl alcohol, benzyl benzoate, benzyl cinnamate, BHA, cetyl esters, cetyl alcohol, citric acid, lanolin, lavender oil, linalyl acetate, liquid paraffin, microcrystalline wax, paraffin wax, propylene glycol, sodium benzoate, sorbitan sesquioleate, stearic acid, water"],"indications_and_usage":["Uses Helps treat and prevent Diaper Rash and Incontinence Dermatitis Protects chafed skin and minor skin irritations due to diaper rash and helps protect from wetness"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away"],"openfda":{"application_number":["M016"],"brand_name":["SUDOCREM SKIN PROTECTANT"],"generic_name":["ZINC OXIDE"],"is_original_packager":[true],"manufacturer_name":["LEDA INNOVATIONS USA, INC."],"package_ndc":["84589-002-10","84589-002-60","84589-002-12","84589-002-25","84589-002-40"],"product_ndc":["84589-002"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["20d2cf0b-d236-fd78-e063-6394a90a8d03"],"spl_set_id":["20d2cf0b-d237-fd78-e063-6394a90a8d03"],"substance_name":["ZINC OXIDE"],"unii":["SOI2LOH54Z"]},"other_safety_information":["Other information Store at room temperature between 15C and 30C (59F to 86F) Do not use if safety seal is broken or missing"],"package_label_principal_display_panel":["Product Packaging 1"],"purpose":["Purpose Skin protectant"],"set_id":"20d2cf0b-d237-fd78-e063-6394a90a8d03","spl_product_data_elements":["SUDOCREM SKIN PROTECTANT ZINC OXIDE WATER LANOLIN LINALYL ACETATE BENZYL CINNAMATE BENZYL BENZOATE SODIUM BENZOATE ZINC OXIDE ZINC OXIDE MICROCRYSTALLINE WAX PARAFFIN PROPYLENE GLYCOL BUTYLATED HYDROXYANISOLE YELLOW WAX BENZYL ALCOHOL LAVENDER OIL SORBITAN SESQUIOLEATE CITRIC ACID MONOHYDRATE STEARIC ACID CETYL ALCOHOL CETYL ESTERS WAX"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if conditions worsens symptoms last more than 7 days or clear up and occur again within a few days"],"version":"1","warnings":["Warnings For external use only. When using this product do not get into eyes Stop use and ask a doctor if conditions worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away"],"when_using":["When using this product do not get into eyes"]}