{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "MAXIMUM STRENGTH Lidocaine Plus Menthol Lidocaine, Menthol LIDOCAINE LIDOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL DIHYDROXYALUMINUM AMINOACETATE GLYCERIN KAOLIN POLYACRYLIC ACID (8000 MW) POLYSORBATE 80 PROPYLENE GLYCOL POVIDONE, UNSPECIFIED SODIUM POLYACRYLATE (8000 MW) TARTARIC ACID TITANIUM DIOXIDE WATER ETHYLHEXYLGLYCERIN PHENOXYETHANOL IODOCARB PETROLATUM CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Lidocaine 4% Topical Anesthetic Menthol 1% Topical Anesthetic"
      ],
      "purpose": [
        "Topical Anesthetic"
      ],
      "indications_and_usage": [
        "USES Temporary relief of minor pain"
      ],
      "warnings": [
        "WARNINGS For External use only. Use only as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. ■ 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. If pregnant or breast feeding Contact a physician prior to use. 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."
      ],
      "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."
      ],
      "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."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast feeding Contact a physician prior to use."
      ],
      "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."
      ],
      "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."
      ],
      "dosage_and_administration": [
        "DIRECTIONS Adults and children 12 years of age and over: Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard after single use. Children under 12 years of age: consult a physician."
      ],
      "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"
      ],
      "storage_and_handling": [
        "Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture."
      ],
      "package_label_principal_display_panel": [
        "Label box"
      ],
      "set_id": "60f72061-d264-424e-b396-5a609076d352",
      "id": "597cb44e-bfe7-a36a-e063-6294a90ab210",
      "effective_time": "20260820",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "MAXIMUM STRENGTH Lidocaine Plus Menthol"
        ],
        "generic_name": [
          "LIDOCAINE, MENTHOL"
        ],
        "manufacturer_name": [
          "ARMY AND AIR FORCE EXCHANGE SERVICE"
        ],
        "product_ndc": [
          "55301-912"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE",
          "MENTHOL, UNSPECIFIED FORM"
        ],
        "rxcui": [
          "1249758"
        ],
        "spl_id": [
          "597cb44e-bfe7-a36a-e063-6294a90ab210"
        ],
        "spl_set_id": [
          "60f72061-d264-424e-b396-5a609076d352"
        ],
        "package_ndc": [
          "55301-912-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0614299793019"
        ],
        "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"
        ]
      }
    }
  ]
}