{"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 or soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 years of age: do not use, consult a doctor."],"effective_time":"20260415","id":"4f85c89b-114c-d84d-e063-6294a90aa32a","inactive_ingredient":["SH Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparabaren and Purified water"],"indications_and_usage":["Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["M016"],"brand_name":["Freskaro Calamine Plus"],"generic_name":["ZINC OXIDE LOTION"],"is_original_packager":[true],"manufacturer_name":["Pharma Nobis, LLC"],"package_ndc":["82645-420-96"],"product_ndc":["82645-420"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1234532"],"spl_id":["4f85c89b-114c-d84d-e063-6294a90aa32a"],"spl_set_id":["4f85bdc7-8fed-f1f5-e063-6394a90a6358"],"substance_name":["ZINC OXIDE","PRAMOXINE HYDROCHLORIDE"],"unii":["SOI2LOH54Z","88AYB867L5"],"upc":["0382645420963"]},"other_safety_information":["Other information Store at room temperature 15 - 30C (59 - 86F)"],"package_label_principal_display_panel":["Freskaro Calamine Plus 2026"],"purpose":["Skin Protectant External Analgesic"],"questions":["Questions or Comments? 1-833-551-0932"],"set_id":"4f85bdc7-8fed-f1f5-e063-6394a90a6358","spl_product_data_elements":["Freskaro 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"],"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"],"version":"1","warnings":["For external use only. Use only as directed. Avoid contact with eyes and mucous membranes,"]}