{"active_ingredient":["Active Ingredients: Menthol USP 4% Purpose Pain Relieving Gel"],"dosage_and_administration":["Directions: 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":"20260513","id":"51b44481-a7ad-8a46-e063-6294a90aefda","inactive_ingredient":["Inactive Ingredients: 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"],"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"],"generic_name":["MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Reckitt Benckiser LLC"],"package_ndc":["59316-102-10","59316-102-11","59316-102-15","59316-102-20","59316-102-25","59316-102-30","59316-102-40","59316-102-50","59316-102-98","59316-102-80","59316-102-12","59316-102-16","59316-102-28","59316-102-90","59316-102-91","59316-102-92"],"product_ndc":["59316-102"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["415974","1111683"],"spl_id":["51b44481-a7ad-8a46-e063-6294a90aefda"],"spl_set_id":["83d5c2f2-2413-4d28-83b2-0808d0917b4d"],"substance_name":["MENTHOL, UNSPECIFIED FORM"],"unii":["L7T10EIP3A"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label CLINICALLY RECOMMENDED ® NDC 59316-102-30 BiOFREEZE ® COOL THE PAIN GEL MENTHOL-PAIN RELIEVING GEL 16 FL OZ (1 PT) 473 mL PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding: Ask a health professional before use"],"purpose":["Purpose Pain Relieving Gel"],"questions":["Questions or Comments: 1-800-246-3733"],"set_id":"83d5c2f2-2413-4d28-83b2-0808d0917b4d","spl_product_data_elements":["BIOFREEZE MENTHOL .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF ARNICA MONTANA FLOWER ARCTIUM LAPPA ROOT FRANKINCENSE CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CAMPHOR (SYNTHETIC) GLYCERIN ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE MELISSA OFFICINALIS LEAF SILICON DIOXIDE TROLAMINE WATER FD&C BLUE NO. 1 FD&C YELLOW NO. 5 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, or in conditions affecting children under 12 years of age"],"storage_and_handling":["Other information - store at 20-25°C (68-77°F) - store in a cool dry place away from direct sunlight"],"version":"35","warnings":["Warnings: 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 If pregnant or breastfeeding: 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"]}