{"active_ingredient":["Roll-on/Overnight Roll-on: Menthol 4%"],"dosage_and_administration":["Directions Directions Roll-on: ■ adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■ children under 2 years of age: consult a physician ■ wash hands after use with cool water Directions Overnight Roll-on: ■ adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■ children under 2 years of age: consult a physician ■ wash hands after use with cool water"],"effective_time":"20260515","id":"51e076b8-984a-b24a-e063-6294a90ae9c0","inactive_ingredient":["Roll-on: Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine,Water, Yellow 5 Overnight Roll-on: Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer Interpolymer, Colloidal Silicon Dioxide, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine"],"indications_and_usage":["Uses Uses Roll-on: Temporarily relieves minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains Uses Overnight Roll-on: Temporarily relieves minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains"],"keep_out_of_reach_of_children":["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."],"openfda":{"application_number":["M017"],"brand_name":["Biofreeze Roll-On and Overnight Roll-On"],"generic_name":["MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Reckitt Benckiser LLC"],"package_ndc":["59316-209-14","59316-205-14","59316-207-14"],"product_ndc":["59316-209"],"product_type":["HUMAN OTC DRUG"],"rxcui":["415974","1111683"],"spl_id":["51e076b8-984a-b24a-e063-6294a90ae9c0"],"spl_set_id":["4d3dcb8f-2075-6bbc-e063-6394a90a4992"]},"package_label_principal_display_panel":["full carton label back label"],"purpose":["Purpose: Pain Relieving Gel"],"questions":["Questions Questions or comments? 1-800-246-3733"],"recent_major_changes":[""],"set_id":"4d3dcb8f-2075-6bbc-e063-6394a90a4992","spl_product_data_elements":["Biofreeze Roll-On and Overnight Roll-On Menthol Biofreeze Roll-on Menthol ISOPROPYL MYRISTATE MELISSA OFFICINALIS LEAF SILICON DIOXIDE BLUE 1 GREEN TEA LEAF WATER MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ARNICA MONTANA FLOWER ISOPROPYL ALCOHOL TROLAMINE FRANKINCENSE GLYCERIN CALENDULA OFFICINALIS FLOWER CAMPHOR (NATURAL) ILEX PARAGUARIENSIS LEAF ALOE VERA LEAF YELLOW 5 ALPHA-TOCOPHEROL ACETATE CARBOMER BIOFREEZE OVERNIGHT ROLL-ON Menthol .ALPHA.-TOCOPHEROL ACETATE ISOPROPYL ALCOHOL WATER GLYCERIN ARNICA MONTANA FLOWER GREEN TEA LEAF FRANKINCENSE ALOE VERA LEAF MENTHOL MENTHOL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) SILICON DIOXIDE ALCOHOL TROLAMINE CALENDULA OFFICINALIS FLOWER ARCTIUM LAPPA ROOT MELISSA OFFICINALIS LEAF ILEX PARAGUARIENSIS LEAF"],"spl_unclassified_section":["Drug Facts"],"storage_and_handling":["Other Information ■ store at 20-25°C (68-77°F) ■ store in a cool dry place away from direct sunlight"],"version":"5","warnings":["Warnings Roll-on: For external use only. Flammable: Keep away from excessive heat or open flame 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, or in conditions affecting children under 12 years of age Warnings Overnight Roll-on: For external use only. Flammable: Keep away from excessive heat or open flame 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 ■ children 2 years to under 12 years of age: use only under adult supervision 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, or in conditions affecting children under 12 years of age"]}