{"active_ingredient":["Calamine 8% Pramoxine HCl 1%"],"dosage_and_administration":["Adults and children 2 years of age and older: Shake well before using. CLeanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton of soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 years of age: Consult a doctor before use."],"effective_time":"20231222","id":"0d1994b2-3c1b-6322-e063-6394a90a1b6c","inactive_ingredient":["SH Alcohol 38B 2.5% Camphor Diazolidinyl Urea Fragrances Glycerin Hydroxypropyl Methylcellulose Methylparaben Polysorbate 80 Propylene Glycol Propylparabaren Purified water"],"indications_and_usage":["Uses: temporarily relieves pain and itching associated with: rashes due to poison ivy, poison oak, or poison sumac insect bites minor skin irritation minor cuts ​dries the oozing and weeping of poison ivy, poison oak and poison sumac"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)"],"openfda":{"application_number":["M016"],"brand_name":["Leader Calamine Plus"],"generic_name":["ZINC OXIDE LOTION"],"is_original_packager":[true],"manufacturer_name":["Cardinal Health, 110 dba Leader"],"package_ndc":["70000-0400-1"],"product_ndc":["70000-0400"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1234532"],"spl_id":["0d1994b2-3c1b-6322-e063-6394a90a1b6c"],"spl_set_id":["81f29789-f794-1e64-e053-2a91aa0ac85e"],"substance_name":["ZINC OXIDE","PRAMOXINE HYDROCHLORIDE"],"unii":["SOI2LOH54Z","88AYB867L5"],"upc":["0096295135145"]},"package_label_principal_display_panel":["calamineplus"],"purpose":["Skin Protectant External Analgesic"],"set_id":"81f29789-f794-1e64-e053-2a91aa0ac85e","spl_product_data_elements":["Leader Calamine Plus zinc oxide lotion ALCOHOL CAMPHOR (SYNTHETIC) DIAZOLIDINYL UREA PROPYLENE GLYCOL HYPROMELLOSES GLYCERIN METHYLPARABEN PROPYLPARABEN POLYSORBATE 80 WATER ZINC OXIDE ZINC CATION PRAMOXINE HYDROCHLORIDE PRAMOXINE"],"version":"5","warnings":["For external use only Avoid contact with eyes and mucous membranes Ask a doctor before using on children under 2 years of age"]}