{
  "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% Gel Patch ALUMINIUM SULFATE OCTADECAHYDRATE SODIUM BORATE PROPYLENE GLYCOL DIHYDROXYALUMINUM AMINOACETATE LIDOCAINE LIDOCAINE SORBITAN MONOOLEATE DMDM HYDANTOIN SODIUM POLYACRYLATE (8000 MW) POLYVINYL ALCOHOL (100000 MW) POLYACRYLIC ACID (250000 MW) TITANIUM DIOXIDE ALUMINUM HYDROXIDE ALPHA-TOCOPHEROL ACETATE TARTARIC ACID WATER GLYCERIN KAOLIN BUTYLATED HYDROXYTOLUENE POVIDONE EDETATE DISODIUM CARBOXYMETHYLCELLULOSE SODIUM"
      ],
      "active_ingredient": [
        "Lidocaine 4%"
      ],
      "indications_and_usage": [
        "Temporarily Relieves Minor Pain"
      ],
      "purpose": [
        "Topical Anesthetic"
      ],
      "warnings": [
        "For external use only"
      ],
      "do_not_use": [
        "More than one patch on your body at a time On cut, irritated swollen skin On puncture wounds For more than one week without consulting a doctor At the same time as other topical analgesics"
      ],
      "when_using": [
        "Use only as directed. Read and follow all directions and warnings on this label. Rare case of serious burns have been reported with products of this type. Do not apply to wounds or damaged, broken or irritated skin. Do not allow contact with the eyes and mucous membranes. 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 analgesic. 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 A transient burning sensation may occur uopn application but generally disappears in several days. If a severe burning sensation occurs, discontinue use immediately. Discontinue use at least 1 hour before a bath or shower. Do not use immediately after a bath or shower."
      ],
      "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": [
        "Adult and children over 12 years Clean and dry affected area. Remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle. Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area. Use 1 patch for up to 12 hours. Children 12 years or younger: ask a doctor"
      ],
      "storage_and_handling": [
        "Store at room temperature 20-25 0 C (68-77 0 F)"
      ],
      "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": [
        "Questions? Call +91-718-739-5680"
      ],
      "dosage_and_administration": [
        "Topical Patch for External Use Only"
      ],
      "package_label_principal_display_panel": [
        "Lidocaine 4% Gel Patch"
      ],
      "set_id": "102399b6-5be9-ee5e-e063-6394a90a3198",
      "id": "4e77f33c-8ab1-be74-e063-6294a90a330e",
      "effective_time": "20260402",
      "version": "4",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Dr Sabharwals"
        ],
        "generic_name": [
          "LIDOCAINE 4% GEL PATCH"
        ],
        "manufacturer_name": [
          "Dr. Sabharwal's Wound Care"
        ],
        "product_ndc": [
          "71318-114"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE"
        ],
        "rxcui": [
          "1737778"
        ],
        "spl_id": [
          "4e77f33c-8ab1-be74-e063-6294a90a330e"
        ],
        "spl_set_id": [
          "102399b6-5be9-ee5e-e063-6394a90a3198"
        ],
        "package_ndc": [
          "71318-114-15"
        ],
        "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"
        ]
      }
    }
  ]
}