{
  "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": 8
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Burn Cream Benzalkonium Chloride, Lidocaine HCI WATER EDETATE DISODIUM PROPYLENE GLYCOL ALOE VERA LEAF MINERAL OIL STEARIC ACID GLYCERIN LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS BENZALKONIUM CHLORIDE BENZALKONIUM TROLAMINE GLYCERYL MONO AND DIPALMITOSTEARATE DIAZOLIDINYL UREA METHYLPARABEN CETYL ALCOHOL PEG-100 STEARATE PROPYLPARABEN"
      ],
      "active_ingredient": [
        "Active Ingredient Lidocaine HCL 0.5%",
        "Benzalkonium Chloride 0.13%"
      ],
      "purpose": [
        "Purpose Topical Analgesic",
        "Purpose First Aid Antiseptic"
      ],
      "indications_and_usage": [
        "Uses Temporary Relief of pain associated with minor cuts, scrapes and burns. Helps protect against harmful bacteria."
      ],
      "warnings": [
        "Warnings For external Use Only Do not use in eyes in large quantities over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns for more than one week unless directed by a doctor"
      ],
      "dosage_and_administration": [
        "Directions Clean the affected area Apply a small amount not more than 3 times daily May be covered with a sterile bandage"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Aloe barbadensis leaf juice, Cetyl alcohol, Diazolidinyl urea, Edetate disodium, glycerin, methylparaben, Mineral oil, Mono and di glycerides, PEG-100 stearate, propylene glycol, propylparaben, stearic acid, triethanolamine, water"
      ],
      "questions": [
        "Questions Call: 1-888-296-9067"
      ],
      "storage_and_handling": [
        "Storage Information Store in cool dry area 15° to 25°C (59° to 77°F). tamper evident sealed packets do not use any opened or torn packets"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "spl_unclassified_section": [
        "Other Information Distributed By: Trifecta Pharmaceuticals USA® 101 NE Third Ave. Ste 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com"
      ],
      "package_label_principal_display_panel": [
        "Package Label R519-539 Globe First Aid Burn Cream 0.9g 10pk 102425 CDER",
        "Package Label R519541 GLOBE FIRST AID BURN CREAM 0.9G 25CT 092623 CDER"
      ],
      "set_id": "087ac43c-1076-d1e2-e063-6294a90a5859",
      "id": "4af5a82b-f212-7f5c-e063-6394a90a6852",
      "effective_time": "20260216",
      "version": "4",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "Burn Cream"
        ],
        "generic_name": [
          "BENZALKONIUM CHLORIDE, LIDOCAINE HCI"
        ],
        "manufacturer_name": [
          "Trifecta Pharmaceuticals USA LLC"
        ],
        "product_ndc": [
          "69396-136"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE",
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1012100"
        ],
        "spl_id": [
          "4af5a82b-f212-7f5c-e063-6394a90a6852"
        ],
        "spl_set_id": [
          "087ac43c-1076-d1e2-e063-6294a90a5859"
        ],
        "package_ndc": [
          "69396-136-10",
          "69396-136-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850058161266",
          "0766588195414"
        ],
        "unii": [
          "F5UM2KM3W7",
          "V13007Z41A"
        ]
      }
    }
  ]
}