{"active_ingredient":["Active ingredients Calamine 8% Zinc oxide 8%"],"adverse_reactions":["Adverse reactions Distributed By: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Rev. 03/25 M-97 Re-order No. 014283"],"dosage_and_administration":["Directions shake well before using apply as needed"],"effective_time":"20260204","id":"4a057dbb-483c-a4b4-e063-6394a90aa36a","inactive_ingredient":["Inactive ingredients bentonite magma, calcium hydroxide, glycerin, purified water"],"indications_and_usage":["Use dries the oozing and weeping of poison: ivy oak sumac"],"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":["Calamine"],"generic_name":["FERRIC OXIDE RED"],"is_original_packager":[true],"manufacturer_name":["Major Pharmaceuticals"],"package_ndc":["0904-2533-21"],"product_ndc":["0904-2533"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["617954"],"spl_id":["4a057dbb-483c-a4b4-e063-6394a90aa36a"],"spl_set_id":["c25be68d-834a-4959-8d47-01ec789406ba"],"substance_name":["FERRIC OXIDE RED","ZINC OXIDE"],"unii":["1K09F3G675","SOI2LOH54Z"]},"package_label_principal_display_panel":["principal display panel NDC 0904-2533-21 MAJOR ® Calamine Lotion Calamine Topical Suspension USP Calamine 8%, Zinc Oxide 8% Skin Protectant dries the oozing and weeping of poison: ivy, oak, and sumac Shake well before using 6 FL OZ (177 mL) image description"],"purpose":["Purpose Skin Protectant"],"questions":["Questions? 1-888-593-0593"],"set_id":"c25be68d-834a-4959-8d47-01ec789406ba","spl_product_data_elements":["Calamine FERRIC OXIDE RED BENTONITE CALCIUM HYDROXIDE GLYCERIN WATER FERRIC OXIDE RED FERRIC OXIDE RED ZINC OXIDE ZINC OXIDE"],"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 store at 59⁰ - 86⁰ F"],"version":"15","warnings":["Warnings For external use only"],"when_using":["When using this product Do not get into eyes"]}