{"active_ingredient":["Active ingredient Calamine 8% Pramoxine HCl 1%"],"dosage_and_administration":["Directions shake well before using adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times daily cleanse the skin with soap and water let dry before use children under 2 years of age: consult a doctor"],"effective_time":"20250819","id":"3cd1933c-6340-50d6-e063-6294a90aca32","inactive_ingredient":["Inactive ingredients benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate"],"indications_and_usage":["Uses temporarily relieves pain and itching associated with: insect bites rashes minor skin irritations 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 right away."],"openfda":{"application_number":["M017"],"brand_name":["Calamine Plus Pramoxine HCl"],"generic_name":["CALAMINE PLUS SPRAY"],"is_original_packager":[true],"manufacturer_name":["FSA Store Inc."],"package_ndc":["81522-959-01"],"product_ndc":["81522-959"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1544717"],"spl_id":["3cd1933c-6340-50d6-e063-6294a90aca32"],"spl_set_id":["3cd18f96-34f7-3f2c-e063-6294a90a3b7e"],"substance_name":["FERRIC OXIDE RED","ZINC OXIDE","PRAMOXINE HYDROCHLORIDE"],"unii":["1K09F3G675","SOI2LOH54Z","88AYB867L5"],"upc":["0810025928988"]},"other_safety_information":["Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.","Other information store between 20° to 25°C (68° to 77°F)"],"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredients in Caladryl Lotion caring mill No-Rub Calamine Plus Spray Calamine 8% / Skin Protectant Pramoxine HCL 1% / External Analgesic Relieves itching from poison ivy, oak & sumac, & insect bites Soothes minor skin irritations & cuts Shake Well Before Use NET WT. 4.1 OZ. (116 g) carton"],"purpose":["Purpose Skin protectant External analgesic"],"questions":["Questions? Call 1-866-964-0939"],"recent_major_changes":["."],"set_id":"3cd18f96-34f7-3f2c-e063-6294a90a3b7e","spl_product_data_elements":["Calamine Plus Pramoxine HCl Calamine Plus Spray BENZYL ALCOHOL CAMPHOR (SYNTHETIC) HYDRATED SILICA ISOBUTANE OLEYL ALCOHOL SORBITAN TRIOLEATE DISTEARDIMONIUM HECTORITE ALCOHOL FERRIC OXIDE RED FERRIC OXIDE RED ZINC OXIDE ZINC CATION PRAMOXINE HYDROCHLORIDE PRAMOXINE"],"stop_use":["Stop use and ask a doctor if conditions worsens symptoms last more than 7 days or clear up and occur again in a few days"],"version":"1","warnings":["Warnings For external use only. Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. When using this product do not get into eyes ask a doctor before using on children under 2 years of age Stop use and ask a doctor if conditions worsens symptoms last more than 7 days or clear up and occur again in a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not get into eyes ask a doctor before using on children under 2 years of age"]}