{"active_ingredient":["Active ingredient Menthol 16%"],"dosage_and_administration":["Directions Adults and children over 12 yrs of age : apply to the affected area no more than 3 to 4 times daily IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER Children 12 years or younger: ask a doctor"],"effective_time":"20241223","id":"29f91a1d-7cce-3cab-e063-6394a90a0274","inactive_ingredient":["Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, Purified Water, SD Alcohol 40 (30%), Triethanolamine"],"indications_and_usage":["Uses Temporarily relieves minor muscle and joint pain associated with arthritis simple backache muscle strains sprains bruises."],"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":["cool and heat pain relieving liquid"],"generic_name":["MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Bionpharma Inc."],"package_ndc":["69452-375-96"],"product_ndc":["69452-375"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["29f91a1d-7cce-3cab-e063-6394a90a0274"],"spl_set_id":["ec6f59d8-45c5-46a0-e053-2995a90a239f"],"substance_name":["MENTHOL"],"unii":["L7T10EIP3A"]},"package_label_principal_display_panel":["Carton *compare to the active ingredient in Icy Hot® a+health™ maximum strength cool & heat pain relieving liquid menthol 16% topical analgesic rool-on applicator no mess dries rapidly stain-free 2.5 fl oz (74mL) carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purpose Topical analgesic"],"questions":["Questions & comments? call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)"],"set_id":"ec6f59d8-45c5-46a0-e053-2995a90a239f","spl_product_data_elements":["cool and heat pain relieving liquid Menthol CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) PROPYLENE GLYCOL TROLAMINE ALCOHOL CAPSAICIN ISOPROPYL MYRISTATE GLYCERIN WATER MENTHOL MENTHOL"],"spl_unclassified_section":["*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Icy Hot®. actual size package containes one bottle DISTRIBUTED BY: Bionpharma Inc., Princeton, NJ 08540 L0000588 R03/22"],"stop_use":["Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days"],"version":"2","warnings":["Warnings For external use only. When using this product: use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin A temporary burning sensation may occur after use but normally disappears in several days. If severe burning sensation occurs, discontinue use immediately If swelling or blistering of the skin occurs, stop use and seek medical attention Do not expose treated area to heat or direct sunlight. Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days Flammable Keep away from fire or flame Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding , ask a health professional before use."],"when_using":["For external use only. When using this product: use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin A temporary burning sensation may occur after use but normally disappears in several days. If severe burning sensation occurs, discontinue use immediately If swelling or blistering of the skin occurs, stop use and seek medical attention Do not expose treated area to heat or direct sunlight."]}