{"active_ingredient":["Calamine 8% Pramoxine Hydochloride 1%"],"dosage_and_administration":["Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 yrs. of age. Consult a doctor before use."],"effective_time":"20231218","id":"0ccb3962-d499-0a6c-e063-6294a90a0d41","inactive_ingredient":["SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water."],"indications_and_usage":["Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations."],"keep_out_of_reach_of_children":["In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately."],"openfda":{"application_number":["M016"],"brand_name":["TopCare Calagesic"],"generic_name":["CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION"],"is_original_packager":[true],"manufacturer_name":["TOPCO ASSOCIATES LLC"],"package_ndc":["36800-268-96"],"product_ndc":["36800-268"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1234532"],"spl_id":["0ccb3962-d499-0a6c-e063-6294a90a0d41"],"spl_set_id":["8dced3ea-147b-3d46-e053-2a95a90aa1c0"],"substance_name":["ZINC OXIDE","PRAMOXINE HYDROCHLORIDE"],"unii":["SOI2LOH54Z","88AYB867L5"],"upc":["0036800443419"]},"package_label_principal_display_panel":["Top Care Calagesic 2022 TCGesig.jpg"],"purpose":["Skin Protectant External analgesic"],"set_id":"8dced3ea-147b-3d46-e053-2a95a90aa1c0","spl_product_data_elements":["TopCare Calagesic calamine and pramoxine hydrochloride lotion GLYCERIN CAMPHOR (NATURAL) POLYSORBATE 80 PROPYLENE GLYCOL DIAZOLIDINYL UREA WATER METHYLPARABEN PROPYLPARABEN ZINC OXIDE ZINC CATION PRAMOXINE HYDROCHLORIDE PRAMOXINE"],"version":"5","warnings":["For external use only. Use only as directed. When using this product. Avoid contact with eyes and moucous membranes."]}