{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "1168 1168 Burn Spray MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL WATER OCTOXYNOL 9 LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS POLYOXYL 40 HYDROGENATED CASTOR OIL GLYCERIN PHENOXYETHANOL TROLAMINE HYPROMELLOSE, UNSPECIFIED PROPYLENE GLYCOL"
      ],
      "active_ingredient": [
        "Active Ingredient Lidocaine Hydrochloride 2%"
      ],
      "purpose": [
        "Purpose Topical Analgesic"
      ],
      "indications_and_usage": [
        "Use(s) For the temporary relief of pain associated with minor burns"
      ],
      "warnings": [
        "Warnings For External Use Only Do not use • Over large areas of the body, particularly over raw surfaces, or blistered areas • Near eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use • Over large areas of the body, particularly over raw surfaces, or blistered areas • Near eyes. If contact occurs, rinse thoroughly with water."
      ],
      "stop_use": [
        "Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions • Adults and children 12 years of age and older: Spray an even layer of burn spray over cleaned, affected area not more than 3 to 4 times daily. • Children under 12 years of age: Consult a doctor before use"
      ],
      "other_safety_information": [
        "Other Information • Store at 20º-25ºC (68º-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Glycerin, Hydroxypropyl Methyl Cellulose, Melaleuca Alterniflia (Tea Tree) Leaf Oil, Octoxynol 9, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Triethanolamine"
      ],
      "questions": [
        "Questions? 1-888-Dynarex Monday - Friday, 9AM - 5PM EST"
      ],
      "package_label_principal_display_panel": [
        "Label 1168 Label 1168_IN_MASTER"
      ],
      "set_id": "1183a4f5-f875-dfb0-e063-6394a90af35f",
      "id": "1183a4f5-f876-dfb0-e063-6394a90af35f",
      "effective_time": "20240216",
      "version": "1",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "1168"
        ],
        "generic_name": [
          "1168 BURN SPRAY"
        ],
        "manufacturer_name": [
          "Dynarex Corporation"
        ],
        "product_ndc": [
          "67777-013"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "spl_id": [
          "1183a4f5-f876-dfb0-e063-6394a90af35f"
        ],
        "spl_set_id": [
          "1183a4f5-f875-dfb0-e063-6394a90af35f"
        ],
        "package_ndc": [
          "67777-013-06",
          "67777-013-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0840117332751"
        ],
        "unii": [
          "V13007Z41A"
        ]
      }
    }
  ]
}