{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 10
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Burn Ease, 3.5g Burn Ease, 3.5g METHYLPARABEN CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) PROPYLENE GLYCOL PROPYLPARABEN WATER TROLAMINE GLYCERIN LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) IMIDUREA MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL"
      ],
      "active_ingredient": [
        "Active Ingredient Lidocaine Hydrochloride 2%"
      ],
      "purpose": [
        "Purpose Analgesic"
      ],
      "indications_and_usage": [
        "Use(s) For the temporary relief of pain associated with • Minor burns • Sunburn"
      ],
      "warnings": [
        "Warnings For External Use Only. Do not use • On wounds or damaged skin • In large quantities, particularly over raw surfaces or blistered areas When using this product • Avoid contact with the eyes • Do not bandage tightly Stop use and ask a doctor if • Condition worsens • Symptoms persist for more than 7 days • Symptoms 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 • On wounds or damaged skin • In large quantities, particularly over raw surfaces or blistered areas"
      ],
      "when_using": [
        "When using this product • Avoid contact with the eyes • Do not bandage tightly"
      ],
      "stop_use": [
        "Stop use and ask a doctor if • Condition worsens • Symptoms persist for more than 7 days • Symptoms 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 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: Consult a doctor"
      ],
      "other_safety_information": [
        "Other Information • Store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Glycerin, Imidazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Leaf Oil, Triethanolamine"
      ],
      "questions": [
        "Questions? 1-888-900-2920 8AM - 4PM PST"
      ],
      "package_label_principal_display_panel": [
        "Label PS-3883 Burn Ease 3.5g PS-3883 MC MASTER"
      ],
      "set_id": "004aa18f-3a97-f454-e063-6394a90afcff",
      "id": "460100cc-1092-14d8-e063-6294a90a62fe",
      "effective_time": "20251215",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Burn Ease, 3.5g"
        ],
        "generic_name": [
          "BURN EASE, 3.5G"
        ],
        "manufacturer_name": [
          "ProStat First Aid LLC"
        ],
        "product_ndc": [
          "58228-3883"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1011852"
        ],
        "spl_id": [
          "460100cc-1092-14d8-e063-6294a90a62fe"
        ],
        "spl_set_id": [
          "004aa18f-3a97-f454-e063-6394a90afcff"
        ],
        "package_ndc": [
          "58228-3883-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "V13007Z41A"
        ]
      }
    }
  ]
}