{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Jelcaine Sterile Lidocaine HCl Jelly USP, 2% HYDROCHLORIC ACID METHYLPARABEN LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS PROPYLPARABEN SODIUM HYDROXIDE HYPROMELLOSES"
      ],
      "active_ingredient": [
        "Active Ingredients Lidocaine HCl 2% w/v"
      ],
      "purpose": [
        "Purpose Topical anesthetic"
      ],
      "indications_and_usage": [
        "Uses For temporary relief of pain and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations"
      ],
      "warnings": [
        "Warnings For external use only."
      ],
      "when_using": [
        "When using this product Avoid contact with eyes. Do not use in large quantities, particularly over raw surfaces or blistered areas."
      ],
      "stop_use": [
        "Stop use and ask a doctor if allergic reaction occurs condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor you experience any redness, irritation, swelling, pain or other symptoms begin or increase"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children PACKAGE NOT CHILD RESISTANT. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 years of age and older: Apply externally to the affected area not more than 3-4 time daily. Children under 2 years of age: Do not use. Consult a doctor."
      ],
      "storage_and_handling": [
        "Other information Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature."
      ],
      "inactive_ingredient": [
        "Inactive ingredients hypromellose, methylparaben, propylparaben, sodium hydroxide. May also contain hydrochloric acid to adjust pH."
      ],
      "package_label_principal_display_panel": [
        "Jelcaine Sterile (Lidocaine HCl Jelly USP) 2% Jelcaine Sterile (Lidocaine HCl Jelly USP (2%)"
      ],
      "set_id": "1a39d1de-7aa2-3068-e063-6394a90aed85",
      "id": "433faabc-d940-29cd-e063-6294a90a4787",
      "effective_time": "20251110",
      "version": "2",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Jelcaine Sterile"
        ],
        "generic_name": [
          "LIDOCAINE HCL JELLY USP, 2%"
        ],
        "manufacturer_name": [
          "Brookfield Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "71351-025"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1011852"
        ],
        "spl_id": [
          "433faabc-d940-29cd-e063-6294a90a4787"
        ],
        "spl_set_id": [
          "1a39d1de-7aa2-3068-e063-6394a90aed85"
        ],
        "package_ndc": [
          "71351-025-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0371351025302"
        ],
        "unii": [
          "V13007Z41A"
        ]
      }
    }
  ]
}