{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 34 } }, "results": [ { "spl_product_data_elements": [ "LidoPro Patch (Lidocaine 4%, Menthol 1%) Lidocaine and Menthol Patch MENTHOL, UNSPECIFIED FORM MENTHOL GLYCERIN POLYSORBATE 80 METHYLPARABEN SODIUM POLYACRYLATE (8000 MW) TARTARIC ACID WATER DIHYDROXYALUMINUM AMINOACETATE POLYACRYLIC ACID (8000 MW) PROPYLPARABEN SODIUM POLYACRYLATE (2500000 MW) KAOLIN EDETATE SODIUM TITANIUM DIOXIDE PROPANEDIOL LIDOCAINE LIDOCAINE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED" ], "active_ingredient": [ "Active ingredient Lidocaine 4% Menthol 1%" ], "purpose": [ "Purpose External Anesthetic External Analgesic" ], "indications_and_usage": [ "Uses For the temporary relief of pain." ], "warnings": [ "Warnings For external use only. Do not use • on the face or rashes, on wounds or damaged skin • in the eyes, mouth, or other mucous membranes • on genitals • with a heating pad • right before or after heart surgery • any patch from a pouch that has been opened for 7 or more days • in large quantities, particularly over raw surfaces or blistered areas • if tamper-evident seal is torn, broken, or missing • more than 2 patches per day unless directed by a doctor • children under 18 years of age Ask a doctor before use if you have • allergies to topical products • high blood pressure, heart disease, or kidney disease When using this product • Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. • The risk of heart attack or stroke may increase if you use more than directed or for longer than directed. Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant of breast-feeding, ask a health professional before use Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If put in mouth, seek medical help or contact a Poison Control Center right away. Dispose if the used patches by folding sticky ends together." ], "do_not_use": [ "Do not use • on the face or rashes, on wounds or damaged skin • in the eyes, mouth, or other mucous membranes • on genitals • with a heating pad • right before or after heart surgery • any patch from a pouch that has been opened for 7 or more days • in large quantities, particularly over raw surfaces or blistered areas • if tamper-evident seal is torn, broken, or missing • more than 2 patches per day unless directed by a doctor • children under 18 years of age" ], "ask_doctor": [ "Ask a doctor before use if you have • allergies to topical products • high blood pressure, heart disease, or kidney disease" ], "when_using": [ "When using this product • Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. • The risk of heart attack or stroke may increase if you use more than directed or for longer than directed." ], "stop_use": [ "Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days." ], "pregnancy_or_breast_feeding": [ "If pregnant of breast-feeding, ask a health professional before use Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If put in mouth, seek medical help or contact a Poison Control Center right away. Dispose if the used patches by folding sticky ends together." ], "dosage_and_administration": [ "Directions Adults 18 years and older: • clean and dry affected area • open pouch and remove one patch • remove protective film from patch • apply one patch to the affected area of pain and leave in place for 8 to 12 hours" ], "other_safety_information": [ "Other information • Some individuals may not experience pain relief until several minutes or hours after applying the patch • avoid storing product in direct sunlight • protect product from excessive moisture • store at 67-77ºF (19-25ºC)" ], "inactive_ingredient": [ "Inactive ingredients Carboxymethylcellose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Kaolin, Methyl parahydroxybenzoate, Partially neutralized Sodium polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl parahydroxybenzoate, Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, water" ], "questions": [ "Questions? Call toll-free (800) 224-2048" ], "package_label_principal_display_panel": [ "402-15 LidoPro® Patch Pain Reliever" ], "set_id": "0976a898-8d79-4b85-b473-c8ad32b4fd00", "id": "0976a898-8d79-4b85-b473-c8ad32b4fd00", "effective_time": "20250520", "version": "1", "openfda": { "application_number": [ "M017" ], "brand_name": [ "LidoPro Patch (Lidocaine 4%, Menthol 1%)" ], "generic_name": [ "LIDOCAINE AND MENTHOL PATCH" ], "manufacturer_name": [ "Preferred Pharmaceuticals Inc." ], "product_ndc": [ "68788-8879" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TRANSDERMAL" ], "substance_name": [ "LIDOCAINE", "MENTHOL, UNSPECIFIED FORM" ], "rxcui": [ "1249758", "2675625" ], "spl_id": [ "0976a898-8d79-4b85-b473-c8ad32b4fd00" ], "spl_set_id": [ "0976a898-8d79-4b85-b473-c8ad32b4fd00" ], "package_ndc": [ "68788-8879-1" ], "original_packager_product_ndc": [ "83881-402" ], "nui": [ "N0000175682", "M0000897", "N0000175426", "N0000175976" ], "pharm_class_epc": [ "Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]" ], "pharm_class_cs": [ "Amides [CS]" ], "pharm_class_pe": [ "Local Anesthesia [PE]" ], "unii": [ "98PI200987", "L7T10EIP3A" ] } } ] }