{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B COCOA BUTTER COTTONSEED OIL OLIVE OIL SODIUM PYRUVATE .ALPHA.-TOCOPHEROL PETROLATUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Manufactured in India MH/DRUGS/28-KD/503"
      ],
      "active_ingredient": [
        "Active ingredients (in each gram) Purpose Bacitracin zinc USP 400 units First aid antibiotic Neomycin sulfate USP 3.5 mg First aid antibiotic Polymyxin B sulfate USP 5,000 units First aid antibiotic"
      ],
      "active_ingredient_table": [
        "<table width=\"75%\"><col width=\"60%\" valign=\"top\" align=\"left\"/><col width=\"40%\" valign=\"top\" align=\"right\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients (in each gram)</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Bacitracin zinc USP 400 units</td><td>First aid antibiotic</td></tr><tr><td>Neomycin sulfate USP 3.5 mg</td><td>First aid antibiotic</td></tr><tr><td>Polymyxin B sulfate USP 5,000 units</td><td>First aid antibiotic</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredients (in each gram) Purpose Bacitracin zinc USP 400 units First aid antibiotic Neomycin sulfate USP 3.5 mg First aid antibiotic Polymyxin B sulfate USP 5,000 units First aid antibiotic"
      ],
      "purpose_table": [
        "<table width=\"75%\"><col width=\"60%\" valign=\"top\" align=\"left\"/><col width=\"40%\" valign=\"top\" align=\"right\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients (in each gram)</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Bacitracin zinc USP 400 units</td><td>First aid antibiotic</td></tr><tr><td>Neomycin sulfate USP 3.5 mg</td><td>First aid antibiotic</td></tr><tr><td>Polymyxin B sulfate USP 5,000 units</td><td>First aid antibiotic</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Uses first aid to help prevent infection in minor: cuts scrapes burns"
      ],
      "warnings": [
        "Warnings For external use only. Do not use if you are allergic to any of the ingredients in the eyes over large areas of the body Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use if you are allergic to any of the ingredients in the eyes over large areas of the body"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns"
      ],
      "stop_use": [
        "Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage"
      ],
      "storage_and_handling": [
        "Other information To open: unscrew cap, pull tab to remove foil seal store at 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date"
      ],
      "inactive_ingredient": [
        "Inactive ingredients cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum"
      ],
      "questions": [
        "Questions? Call 1-866-923-4914"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton jpg"
      ],
      "set_id": "5b14499e-e45c-7c05-e063-6294a90a1cc2",
      "id": "5b1449dd-e322-db49-e063-6394a90a0e5c",
      "effective_time": "20260909",
      "version": "1",
      "openfda": {
        "application_number": [
          "M004"
        ],
        "brand_name": [
          "Triple Antibiotic"
        ],
        "generic_name": [
          "BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE"
        ],
        "manufacturer_name": [
          "NuCare Pharmaceutical, Inc."
        ],
        "product_ndc": [
          "68071-3754"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BACITRACIN ZINC",
          "NEOMYCIN SULFATE",
          "POLYMYXIN B SULFATE"
        ],
        "rxcui": [
          "204602"
        ],
        "spl_id": [
          "5b1449dd-e322-db49-e063-6394a90a0e5c"
        ],
        "spl_set_id": [
          "5b14499e-e45c-7c05-e063-6294a90a1cc2"
        ],
        "package_ndc": [
          "68071-3754-1"
        ],
        "original_packager_product_ndc": [
          "51672-2120"
        ],
        "upc": [
          "0368071375411"
        ],
        "unii": [
          "89Y4M234ES",
          "057Y626693",
          "19371312D4"
        ]
      }
    }
  ]
}