{"active_ingredient":["Active ingredient Benzocaine USP 20% Menthol USP 1%"],"dosage_and_administration":["Directions Children under 2 yrs. ▪ Do not use ▪ Consult doctor Adults and children 2 yrs. and older ▪ Clean area ▪ Apply to affected area as needed not more than 3 to 4 times a day."],"effective_time":"20190412","id":"a2ae5bf8-117b-4c44-bb0c-4f1b6dbaf25a","inactive_ingredient":["Inactive Ingredients FD&C Blue #1, Isopropyl Alcohol 15%, PEG-8 Laurate, Water."],"indications_and_usage":["Uses ▪ Temporarily relieves pain and itching of fire ant bites and stings, insect bites and stings, and minor skin irritation."],"keep_out_of_reach_of_children":["Keep Out of Reach of Children If swallowed get medical help or contact Poison Control Center right away."],"openfda":{"application_number":["part348"],"brand_name":["Fire Out"],"generic_name":["BENZOCAINE AND MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Randob Ltd."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["52412-300-10","52412-300-20"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_epc":["Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["52412-300"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1552282","1866401"],"spl_id":["a2ae5bf8-117b-4c44-bb0c-4f1b6dbaf25a"],"spl_set_id":["77ab634e-13d4-4f5f-87c8-73976e65a842"],"substance_name":["BENZOCAINE","MENTHOL, UNSPECIFIED FORM"],"unii":["U3RSY48JW5","L7T10EIP3A"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel NEW! KILLS THE PAIN STOPS THE ITCH FIRE OUT™ INSTANT PAIN RELIEF from: Fire Ant Stings also from: Mosquito Bites Insect Bites Jellyfish Stings Bee Stings MAXIMUM STRENGTH PAIN RELIEVING LIQUID NO-MESS ROLL-ON 1.7 fl oz (50 ml) MADE IN THE USA DUAL ACTION carton-label-bottle"],"purpose":["Purpose (for pain) Topical Anesthetic (anti-itch) Antipruritic"],"set_id":"77ab634e-13d4-4f5f-87c8-73976e65a842","spl_product_data_elements":["Fire Out Benzocaine and Menthol BENZOCAINE BENZOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM FD&C BLUE NO. 1 ISOPROPYL ALCOHOL PEG-8 LAURATE WATER Blue"],"version":"3","warnings":["Warnings ▪ For external use only ▪ Do not apply over large areas of the body ▪ Avoid contact with eyes, mouth, and mucous membranes"]}