{"active_ingredient":["Active ingredient Menthol 5%"],"dosage_and_administration":["Directions adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. Use on affected area not more than 3 to 4 times daily. children under 12 years of age: consult a physician wash hands after use with cool water"],"effective_time":"20260513","id":"51b56b5f-5a3c-cc70-e063-6294a90a4580","inactive_ingredient":["Inactive ingredients 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum, Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide"],"indications_and_usage":["Uses Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains"],"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":["Biofreeze Menthol"],"generic_name":["MENTHOL, UNSPECIFIED FORM"],"is_original_packager":[true],"manufacturer_name":["Reckitt Benckiser LLC"],"package_ndc":["59316-887-04","59316-992-32","59316-992-33"],"product_ndc":["59316-887"],"product_type":["HUMAN OTC DRUG"],"rxcui":["420222","2109627"],"spl_id":["51b56b5f-5a3c-cc70-e063-6294a90a4580"],"spl_set_id":["3f2b1f48-2d78-4985-a046-9f72de5e1a9b"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Kit Carton CLINICALLY RECOMMENDED* NDC 59316-887-04 BiOFREEZE ® COOL THE PAIN EXTRA LARGE PATCHES MENTHOL-PAIN RELIEVING PATCH Designed to provide up to 8 hours of long lasting pain relief Proven cold therapy formula for sore muscles, simple backaches, and joint pain Flexible fabric for superior performance and comfort 4 PATCHES | 2 SIZES EXTRA LARGE AND LONG 2 EXTRA LARGE 9.84 in x 5.5 in (25 cm x 14 cm) each 2 LONG 7.87 in x 3.94 in (20 cm x 10 cm) each Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain Relieving Patch"],"questions":["Questions or comments? 1-800-246-3733"],"set_id":"3f2b1f48-2d78-4985-a046-9f72de5e1a9b","spl_product_data_elements":["Biofreeze Menthol Menthol, Unspecified form Biofreeze Menthol Menthol, Unspecified form ALOE VERA LEAF ARNICA MONTANA FLOWER FRANKINCENSE GREEN TEA LEAF CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED DIHYDROXYALUMINUM AMINOACETATE ETHYLHEXYLGLYCERIN GLYCERIN IODOPROPYNYL BUTYLCARBAMATE KAOLIN MINERAL OIL PHENOXYETHANOL PETROLATUM POLYACRYLIC ACID (450000 MW) POLYSORBATE 80 PROPYLENE GLYCOL POVIDONE, UNSPECIFIED SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID TITANIUM DIOXIDE WATER MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM 1,2-HEXANEDIOL Biofreeze Menthol Menthol, Unspecified form 1,2-HEXANEDIOL ALOE VERA LEAF ARNICA MONTANA FLOWER FRANKINCENSE GREEN TEA LEAF CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED DIHYDROXYALUMINUM AMINOACETATE ETHYLHEXYLGLYCERIN GLYCERIN IODOPROPYNYL BUTYLCARBAMATE KAOLIN MINERAL OIL PHENOXYETHANOL PETROLATUM POLYACRYLIC ACID (450000 MW) POLYSORBATE 80 PROPYLENE GLYCOL POVIDONE, UNSPECIFIED SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID TITANIUM DIOXIDE WATER MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM"],"spl_unclassified_section":["Drug Facts","Dist. by: RB Health (US) Parsippany, NJ 07054-0224"],"stop_use":["Stop use and ask a doctor if you experience pain, swelling or blistering of the skin condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days arthritic pain persists for more than 10 days, or redness is present"],"storage_and_handling":["Other information store at 20-25°C (68-77°F) store in a cool dry place away from direct sunlight"],"version":"4","warnings":["Warnings For external use only. When using this product use only as directed avoid contact with the eyes or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if excessive irritation develops do not bandage tightly or use with heating pad or device Stop use and ask a doctor if you experience pain, swelling or blistering of the skin condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days arthritic pain persists for more than 10 days, or redness is present If pregnant or breast-feeding, ask a health professional before use. 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 use only as directed avoid contact with the eyes or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if excessive irritation develops do not bandage tightly or use with heating pad or device"]}