{"active_ingredient":["Active ingredient Menthol 4%"],"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":"20241111","how_supplied":["HOW SUPPLIED Product: 50090-6361 NDC: 50090-6361-0 89 mL in a BOTTLE"],"id":"d27f9f48-e60b-4599-a1d6-d243dfcabda5","inactive_ingredient":["Inactive ingredients Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, 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"],"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":["M012"],"brand_name":["Biofreeze Colorless"],"generic_name":["MENTHOL"],"manufacturer_name":["A-S Medication Solutions"],"original_packager_product_ndc":["59316-103"],"package_ndc":["50090-6361-0"],"product_ndc":["50090-6361"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["415974","1111683"],"spl_id":["d27f9f48-e60b-4599-a1d6-d243dfcabda5"],"spl_set_id":["cc1cba14-da40-4d7d-b522-b5c648798e96"],"substance_name":["MENTHOL"],"unii":["L7T10EIP3A"]},"package_label_principal_display_panel":["BIOFREEZE COLORLESS Label Image"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain Relieving Gel"],"questions":["Questions or comments? 1-800-246-3733"],"set_id":"cc1cba14-da40-4d7d-b522-b5c648798e96","spl_product_data_elements":["Biofreeze Colorless MENTHOL MENTHOL MENTHOL ALOE BARBADENSIS LEAF JUICE POWDER ARCTIUM LAPPA ROOT ARNICA MONTANA FLOWER FRANKINCENSE CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CAMPHOR (SYNTHETIC) CARBOMER GLYCERIN ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE MELISSA OFFICINALIS LEAF SILICA ALPHA-TOCOPHEROL ACETATE TROLAMINE AQUA"],"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":"4","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 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"]}