{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Dr Sabharwals Lidocaine 4% and Menthol 1% Patch ALUMINIUM SULFATE OCTADECAHYDRATE LIDOCAINE LIDOCAINE MENTHOL MENTHOL WATER SORBITAN MONOOLEATE POLYACRYLIC ACID (250000 MW) KAOLIN ALPHA-TOCOPHEROL ACETATE DMDM HYDANTOIN SODIUM POLYACRYLATE (8000 MW) POLYVINYL ALCOHOL (100000 MW) TARTARIC ACID TITANIUM DIOXIDE GLYCERIN ALUMINUM HYDROXIDE PROPYLENE GLYCOL EDETATE DISODIUM POVIDONE CARBOXYMETHYLCELLULOSE SODIUM BORAX SILICON DIOXIDE BUTYLATED HYDROXYTOLUENE DIHYDROXYALUMINUM AMINOACETATE"
      ],
      "active_ingredient": [
        "Lidocaine 4% Menthol 1%"
      ],
      "purpose": [
        "Topical Anesthetic"
      ],
      "intended_use_of_the_device": [
        "Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises."
      ],
      "warnings": [
        "For external use only"
      ],
      "do_not_use": [
        "more than 1 patch on your body at a time or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor"
      ],
      "when_using": [
        "use only as directed. Read and follow all directions and warnings on this label. do not allow contact with the eyes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch."
      ],
      "ask_doctor": [
        "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"
      ],
      "pregnancy_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."
      ],
      "instructions_for_use": [
        "Adults and children over 12 years: clean and dry affected area remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 1 patch for up to 12 hours children 12 years or younger: ask a doctor"
      ],
      "inactive_ingredient": [
        "Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide."
      ],
      "questions": [
        "Call +91-905-677-0088"
      ],
      "dosage_and_administration": [
        "Topical Patch for external use only"
      ],
      "indications_and_usage": [
        "Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises."
      ],
      "package_label_principal_display_panel": [
        "Lidocaine 4% Menthol 1% Patch"
      ],
      "set_id": "10249d0f-5ee1-6892-e063-6394a90a967e",
      "id": "491bb313-88d4-3f92-e063-6394a90a06de",
      "effective_time": "20260123",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Dr Sabharwals"
        ],
        "generic_name": [
          "LIDOCAINE 4% AND MENTHOL 1% PATCH"
        ],
        "manufacturer_name": [
          "Dr. Sabharwal's Wound Care"
        ],
        "product_ndc": [
          "71318-115"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE",
          "MENTHOL"
        ],
        "rxcui": [
          "1249758"
        ],
        "spl_id": [
          "491bb313-88d4-3f92-e063-6394a90a06de"
        ],
        "spl_set_id": [
          "10249d0f-5ee1-6892-e063-6394a90a967e"
        ],
        "package_ndc": [
          "71318-115-15"
        ],
        "is_original_packager": [
          true
        ],
        "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"
        ]
      }
    }
  ]
}