{"active_ingredient":["Active ingredient: Lidocaine 4% Purpose: Pain Relieving Patch"],"dosage_and_administration":["Directions 􀂄 adults and children 12 years of age and older: Clean and dry affected area, cut open pouch and remove patch from protective film by first peeling back center film. Apply exposed patch to affected area. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. (see images on carton) 􀂄 use 1 patch at a time and 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":"20260602","id":"5348f92e-a770-de13-e063-6294a90adbcc","inactive_ingredient":["Inactive ingredients: Butylated Hydroxytoluene, Glyceryl Hydrogenated Rosinate, Mineral Oil, Polyisobutylene, Styrene/Isoprene/Styrene Block Copolymer"],"indications_and_usage":["Uses For the temporary relief of pain"],"keep_out_of_reach_of_children":["Keep out of reach of children and pets . If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M017"],"brand_name":["Biofreeze Ultraflex"],"generic_name":["LIDOCAINE"],"is_original_packager":[true],"manufacturer_name":["Reckitt Benckiser LLC"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["59316-899-04","59316-899-07"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["59316-899"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1737778"],"spl_id":["5348f92e-a770-de13-e063-6294a90adbcc"],"spl_set_id":["2655974b-a67d-9f07-e063-6294a90a54e8"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"],"upc":["0731124444967"]},"other_safety_information":["Other information 􀂄 store at 20-25°C (68-77°F) 􀂄 store in a cool dry place away from direct sunlight"],"package_label_principal_display_panel":["Label Label carton label"],"purpose":["Uses Uses For the temporary relief of pain"],"questions":["Questions or comments? 1-866-682-4639"],"recent_major_changes":[""],"set_id":"2655974b-a67d-9f07-e063-6294a90a54e8","spl_product_data_elements":["Biofreeze Ultraflex Lidocaine GLYCEROL ESTER OF HYDROGENATED ROSIN BUTYLATED HYDROXYTOLUENE POLYISOBUTYLENE (55000 MW) STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER MINERAL OIL LIDOCAINE LIDOCAINE"],"version":"5","warnings":["Warnings For external use only. Do not use 􀂄 more than 1 patch on your body at a time or with other topical anesthetics at the same time 􀂄 on wounds, damaged skin, rashes, or swollen skin 􀂄 with a heating pad or apply local heat to the area of use 􀂄 in large quantities, particularly over raw surfaces or blistered areas When using this product 􀂄 use only as directed 􀂄 do not bandage tightly 􀂄 avoid contact with the eyes or on mucous membranes 􀂄 dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. Stop use and ask a doctor if 􀂄 the condition for which this preparation is used persists or if a rash, redness or irritation develops 􀂄 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within few days 􀂄 you experience pain, swelling or blistering of the skin If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children and pets . If swallowed, get medical help or contact a Poison Control Center right away."]}