{"active_ingredient":["Active ingredient Zinc Oxide 20.0% (3.0% as Calamine)"],"do_not_use":["Do not use on deep or puncture wounds animal bites serious burns"],"dosage_and_administration":["Directions Cleanse skin with THERA TM Moisturizing Body Cleanser or THERA TM Foaming Body Cleanser Apply paste to area as needed For G-tubes, cleanse as above, apply thin layer and secure with drain sponge or product as directed"],"effective_time":"20240617","id":"1b1bf6ec-a0cf-df7a-e063-6394a90af9f6","inactive_ingredient":["Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, SAFFLEX TM (Consisting of: Calcium Pantothenate (Vitamin B 5 ), Maltodexdrin, Niacinamide (Vitamin B 3 ), Pyridoxine HCl (Vitamin B 6 ), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E)), Bisabolol, Carthamus Tinctorius (Safflower) Olesomes, Carthamus Tinctorius (Safflower) Seed Oil, Lavender Ylang Fragrance, Modified Corn Starch, Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate, Petrolatum, Phenoxyethanol, Sodium Hyaluronate, Zingiber Officinale (Ginger) Root Extract."],"indications_and_usage":["Uses For the treatment and/or prevention of diaper rash temporarily protects and helps relieve minor skin irritation and itching due to rashes"],"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":["THERA Calazinc Body Shield"],"generic_name":["ZINC OXIDE"],"is_original_packager":[true],"manufacturer_name":["McKesson Medical-Surgical Inc."],"package_ndc":["68599-0205-4","68599-0205-1"],"product_ndc":["68599-0205"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["1b1bf6ec-a0cf-df7a-e063-6394a90af9f6"],"spl_set_id":["974b1046-83ee-4207-91d3-40982beb9c63"],"substance_name":["ZINC OXIDE"],"unii":["SOI2LOH54Z"]},"package_label_principal_display_panel":["Label (4 oz) NDC 68599-0205-4 Thera Calazinc Body Shield Net Contents 4 fl oz (113 mL) MFR# 53-CZ4 each","Label(4 g) NDC 68599-0205-1 Thera Calazinc Body Shield Net Weight 4 g (0.14 oz) MFR# 53-CZ4G box each"],"purpose":["Purpose Skin Protectant"],"set_id":"974b1046-83ee-4207-91d3-40982beb9c63","spl_product_data_elements":["THERA Calazinc Body Shield Zinc Oxide HISTIDINE TYROSINE LYSINE ISOLEUCINE KUKUI NUT OIL ALOE VERA LEAF CALCIUM PANTOTHENATE MALTODEXTRIN NIACINAMIDE PYRIDOXINE HYDROCHLORIDE SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE, DL- LEVOMENOL SAFFLOWER OIL PETROLATUM HYALURONATE SODIUM GINGER ZINC OXIDE ZINC OXIDE ASPARTIC ACID ALANINE PROLINE MINERAL OIL VALINE WATER SERINE CHLORPHENESIN OCTENYLSUCCINIC ACID GLYCINE CAPRYLYL GLYCOL CARTHAMUS TINCTORIUS SEED OLEOSOMES PHENYLALANINE ZEA MAYS WHOLE LEUCINE ARGININE BUTYLENE GLYCOL ZINC CARBONATE ZINC CATION THREONINE GLUTAMIC ACID"],"stop_use":["Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days"],"storage_and_handling":["Other information Protect from freezing. Avoid excessive heat."],"version":"5","warnings":["Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days"],"when_using":["When using this product do not get into eyes"]}