{
  "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": [
        "First Aid Antibiotic plus Burn Relief Bacitracinzinc,NeomycinSulfate,PolymxinBSulfate,PramoxineHCI PRAMOXINE HYDROCHLORIDE PRAMOXINE POLYMYXIN B SULFATE POLYMYXIN B BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN WHITE PETROLATUM"
      ],
      "active_ingredient": [
        "Active Ingredient Pramoxine HCI",
        "Active Ingredient Polymyxin B Sulfate",
        "Active Ingredient Bacitracin Zinc",
        "Neomycin Sulfate"
      ],
      "purpose": [
        "Purpose Section External Analgesic",
        "Purpose First Aid Antibiotic",
        "Purpose First Aid Antibiotic",
        "Purpose First Aid Antibiotic"
      ],
      "indications_and_usage": [
        "Uses First Aid to help prevent infection and for the temporary relief of pain or discomfort in minor cuts, scrapes and burns."
      ],
      "warnings": [
        "Warnings For external Use Only"
      ],
      "do_not_use": [
        "Do Not Use Do Not use In the eyes Over large areas of the body If you are allergic to any of the ingredients"
      ],
      "ask_doctor": [
        "Ask Doctor before use if you have Deep or puncture wounds Animal Bites Serious Burns"
      ],
      "stop_use": [
        "Stop Use and ask a doctor if Condition persists or gets worse You need to use longer than 1 week A rash or other allergic reaction develops symptoms persist for more than 1 week or clear up and occur again within a few days"
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 years of age and older: Clean the affected area and dry thoroughly. Apply a small amount of this product , an mount equal to the surgace area of the tip of a finger) on the area 1 to 3 times daily May be covered with a sterile bandage Children under 2 years old: ask a doctor"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients White Petrolatum"
      ],
      "questions": [
        "Questions Call 1-888-296-9067"
      ],
      "storage_and_handling": [
        "Storage Information Store at 20° to 25°C (68° to 77°F). See carton or tube crimp for lot number and expiration date"
      ],
      "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 Avenue, Suite 1500 Fort Lauderdale, FL. 33301 USA www.trifecta-pharma.com"
      ],
      "package_label_principal_display_panel": [
        "Globe First Aid Antibiotic and Burn Relief 2oz Rev13 082523 CDER"
      ],
      "set_id": "048871e2-c917-292d-e063-6394a90af130",
      "id": "298dae2b-f42d-53a1-e063-6394a90a223b",
      "effective_time": "20241218",
      "version": "2",
      "openfda": {
        "application_number": [
          "M004"
        ],
        "brand_name": [
          "First Aid Antibiotic plus Burn Relief"
        ],
        "generic_name": [
          "BACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCI"
        ],
        "manufacturer_name": [
          "Trifecta Pharmaceuticals USA LLC"
        ],
        "product_ndc": [
          "69396-138"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BACITRACIN ZINC",
          "NEOMYCIN SULFATE",
          "POLYMYXIN B SULFATE",
          "PRAMOXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1359350"
        ],
        "spl_id": [
          "298dae2b-f42d-53a1-e063-6394a90a223b"
        ],
        "spl_set_id": [
          "048871e2-c917-292d-e063-6394a90af130"
        ],
        "package_ndc": [
          "69396-138-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850026393897"
        ],
        "unii": [
          "89Y4M234ES",
          "057Y626693",
          "19371312D4",
          "88AYB867L5"
        ]
      }
    }
  ]
}