{"active_ingredient":["Lidocaine 4% Menthol 1%"],"do_not_use":["■ More than one patch on your body at a time ■ On cut, irritated or swollen skin ■ On puncture wounds ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients ■ If pouch is damaged or opened."],"dosage_and_administration":["DIRECTIONS Adults and children 12 years of age and over: Adults and children 12 years of age and over: Use as directed Clean and dry affected area, free of lotions, ointments and creams Carefully remove backing from patch starting at a corner Apply sticky side of patch to affected area Do not use more than one patch in a 12 hour period Maximum 2 patches per day Discard patch after single use Children under 12 years of age: Consult a physician"],"effective_time":"20260514","id":"51c99f5c-204c-dd76-e063-6294a90a4a56","inactive_ingredient":["INACTIVE INGREDIENTS carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, ethylhexylglycerin, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water"],"indications_and_usage":["USES Temporarily relieves minor pain"],"keep_out_of_reach_of_children":["If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["M017"],"brand_name":["Cold and Heat Lidocaine Patch Plus Menthol"],"generic_name":["LIDOCAINE, MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Cardinal Health, 110 dba LEADER"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["70000-0558-1"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["70000-0558"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1249758"],"spl_id":["51c99f5c-204c-dd76-e063-6294a90a4a56"],"spl_set_id":["77066d01-75b0-4a8d-88d3-c639626d3326"],"substance_name":["LIDOCAINE","MENTHOL, UNSPECIFIED FORM"],"unii":["98PI200987","L7T10EIP3A"]},"package_label_principal_display_panel":["Lidocaine + Menthol Patch label"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding ask a health professional before use"],"purpose":["External analgesic"],"set_id":"77066d01-75b0-4a8d-88d3-c639626d3326","spl_product_data_elements":["Cold and Heat Lidocaine Patch Plus Menthol Lidocaine, Menthol CARBOXYMETHYLCELLULOSE SODIUM DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS GLYCERIN KAOLIN ETHYLHEXYLGLYCERIN POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 PROPYLENE GLYCOL PHENOXYETHANOL POVIDONE, UNSPECIFIED SODIUM POLYACRYLATE (8000 MW) TARTARIC ACID TITANIUM DIOXIDE WATER LIDOCAINE LIDOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL PETROLATUM IODOPROPYNYL BUTYLCARBAMATE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and consult a doctor if ■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied."],"storage_and_handling":["Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture."],"version":"6","warnings":["WARNINGS For External use only. ■ More than one patch on your body at a time ■ On cut, irritated or swollen skin ■ On puncture wounds ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients ■ If pouch is damaged or opened. WHEN USING: ■ Use only as directed ■ Read and follow all directions and warnings on this carton ■ Do not allow contact with the eyes ■ Do not use at the same time as other topical analgesics ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■ 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 consult a doctor if ■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied. If pregnant or breast feeding ask a health professional before use If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["WHEN USING: ■ Use only as directed ■ Read and follow all directions and warnings on this carton ■ Do not allow contact with the eyes ■ Do not use at the same time as other topical analgesics ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■ 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."]}