{"active_ingredient":["Active ingredient Menthol 1%"],"dosage_and_administration":["Directions Adults and children 12 years of age or older: Apply to affected area no more than 3 to 4 times daily. Children under 12 years of age, consult a physician Cleanse and dry skin. May be used with wet or dry bandages in conjuction with ice packs."],"effective_time":"20250722","id":"3a876b4d-bba4-c8d4-e063-6394a90abaa0","inactive_ingredient":["Inactive ingredients camphor, carbomer 940, FD&C blue #1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, polysorbate 20, purified water, triethanolamine"],"indications_and_usage":["Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises and sprains."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental ingestion, contact a doctor or a Poison Control Center right away."],"openfda":{"application_number":["M017"],"brand_name":["Hielo Ardiente"],"generic_name":["MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Menper Distributors, Inc."],"package_ndc":["53145-002-01"],"product_ndc":["53145-002"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1039043"],"spl_id":["3a876b4d-bba4-c8d4-e063-6394a90abaa0"],"spl_set_id":["97ec516c-d2bc-47ce-82fe-bd68445d9570"],"substance_name":["MENTHOL"],"unii":["L7T10EIP3A"],"upc":["0042279419169"]},"package_label_principal_display_panel":["Hielo"],"purpose":["Purpose Analgesic"],"set_id":"97ec516c-d2bc-47ce-82fe-bd68445d9570","spl_product_data_elements":["Hielo Ardiente Menthol CAMPHOR (SYNTHETIC) CARBOMER 940 FD&C BLUE NO. 1 ISOPROPYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE POLYSORBATE 20 WATER TRIETHANOLAMINE BENZOATE MENTHOL MENTHOL"],"version":"4","warnings":["Warnings For external use only Avoid contact with eyes Do not use if condition worsens If symptoms persist for more than 5 days or recur, discontinue use and consult a physician Do not apply to open wounds or damaged skin Do not bandage tightly Do not use with heating pads or heating devices Use only as directed"]}