{"active_ingredient":["Active Ingredients: Menthol USP 10% Purpose Cooling Pain Relief"],"dosage_and_administration":["Directions: ■ adults and children 12 years of age and older : rub a thin film over 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":"51b574d1-9ee5-b2aa-e063-6294a90a5a3f","inactive_ingredient":["Inactive Ingredients: Alcohol, Calcium Gluconate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetostearyl Alcohol, Dimethicone, Edetate Sodium, Fragrance, Gluconolactone, Glycerin, Glyceryl Stearate, Grapeseed Oil Refined, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Isopropyl Alcohol, PEG-4 Laurate, Phenoxyethanol, Polysorbate 60, PurifiedWater, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate"],"indications_and_usage":["Uses: Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • backache • strains • sprains •bruises 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: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur If pregnant or breastfeeding: Ask a health professional before use Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately"],"keep_out_of_reach_of_children":["Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately"],"openfda":{"application_number":["M017"],"brand_name":["Biofreeze"],"generic_name":["MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Reckitt Benckiser LLC"],"package_ndc":["59316-870-10"],"product_ndc":["59316-870"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["253020","2001133"],"spl_id":["51b574d1-9ee5-b2aa-e063-6294a90a5a3f"],"spl_set_id":["10a8face-47da-ebbe-e063-6294a90a42fe"],"substance_name":["MENTHOL, UNSPECIFIED FORM"],"unii":["L7T10EIP3A"]},"package_label_principal_display_panel":["Package Labeling: Label"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding: Ask a health professional before use"],"purpose":["Purpose Cooling Pain Relief"],"questions":["Questions or Comments: 1-800-246-3733"],"recent_major_changes":[""],"set_id":"10a8face-47da-ebbe-e063-6294a90a42fe","spl_product_data_elements":["Biofreeze MENTHOL ALCOHOL CETOSTEARYL ALCOHOL ISOPROPYL ALCOHOL PEG-4 LAURATE GLYCERIN CALCIUM GLUCONATE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL DIMETHICONE GLUCONOLACTONE GLYCERYL MONOSTEARATE HYDROXYACETOPHENONE ILEX PARAGUARIENSIS LEAF IODOPROPYNYL BUTYLCARBAMATE PHENOXYETHANOL POLYSORBATE 60 SODIUM BENZOATE SODIUM HYDROXIDE SODIUM STEAROYL LACTYLATE EDETATE SODIUM .ALPHA.-TOCOPHEROL ACETATE GRAPE SEED OIL WATER MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur"],"version":"8","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: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur If pregnant or breastfeeding: Ask a health professional before use Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately"],"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"]}