{"active_ingredient":["Active ingredient Menthol 5.6%"],"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. do not stretch the patch during application as it should be comfortable and not tight do not overwrap or wrap patches over themselves for best adhesion: area should be clean, dry, and smooth children under 12 years of age: consult a physician wash hands after use with cool water"],"effective_time":"20260513","id":"51b597cc-806d-e160-e063-6394a90ac1be","inactive_ingredient":["Inactive ingredients Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Benzalkonium Chloride, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Isopropyl Myristate, Kaolin, L-Tartaric Acid, Lauralkonium Chloride, Mineral Oil, Nonoxynol-10, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium Dioxide, 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":["M017"],"brand_name":["Biofreeze Flexible Relief Strip"],"generic_name":["MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Reckitt Benckiser LLC"],"package_ndc":["59316-004-01","59316-004-04"],"product_ndc":["59316-004"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2566836"],"spl_id":["51b597cc-806d-e160-e063-6394a90ac1be"],"spl_set_id":["6ec26bae-e395-49aa-969e-8c653d6f0b27"],"substance_name":["MENTHOL, UNSPECIFIED FORM"],"unii":["L7T10EIP3A"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 4 Strip Carton CLINICALLY RECOMMENDED* NDC 59316-004-04 BiOFREEZE ® COOL THE PAIN FLEXIBLE RELIEF STRIPS MENTHOL-PAIN RELIEVING PATCH Designed to provide up to 8 hours of long lasting pain relief Strong adhesion to stay through any movement Optimal thickness for comfort and flexiblity 4 STRIPS | EXTRA LONG 10 in x 2 in (25.4 cm x 5 cm) each PRINCIPAL DISPLAY PANEL - 4 Strip Carton"],"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":"6ec26bae-e395-49aa-969e-8c653d6f0b27","spl_product_data_elements":["Biofreeze Flexible Relief Strip MENTHOL MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ALOE VERA LEAF ARNICA MONTANA FLOWER BENZALKONIUM CHLORIDE FRANKINCENSE GREEN TEA LEAF CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED DIHYDROXYALUMINUM AMINOACETATE EDETATE DISODIUM GLYCERIN ISOPROPYL MYRISTATE KAOLIN TARTARIC ACID LAURALKONIUM CHLORIDE MINERAL OIL NONOXYNOL-10 PETROLATUM POLYSORBATE 80 PROPYLENE GLYCOL POVIDONE, UNSPECIFIED TITANIUM DIOXIDE WATER"],"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":"5","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"]}