{
  "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": 12
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate PETROLATUM PARAFFINUM LIQUIDUM BACITRACIN ZINC BACITRACIN POLYMYXIN B SULFATE POLYMYXIN B"
      ],
      "description": [
        "DESCRIPTION Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP is a sterile antimicrobial ointment formulated for ophthalmic use. Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units/mg. The structural formula for bacitracin A is: Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units/mg, calculated on an anhydrous basis. The structural formulae are: Each gram contains: Actives: bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units; Inactives: mineral oil and white petrolatum. bacitracinchemstructure polychemstructure"
      ],
      "clinical_pharmacology": [
        "CLINICAL PHARMACOLOGY Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and Haemophilus influenzae species. Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci."
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate."
      ],
      "contraindications": [
        "CONTRAINDICATIONS This product is contraindicated in those individuals who have shown hypersensitivity to any of its components."
      ],
      "warnings": [
        "WARNINGS Ophthalmic ointments may retard corneal healing."
      ],
      "spl_unclassified_section": [
        "PRECAUTIONS As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs."
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection. FOR OPHTHALMIC USE ONLY"
      ],
      "how_supplied": [
        "HOW SUPPLIED Product: 50090-7189 NDC: 50090-7189-0 3.5 g in a TUBE / 144 in a CASE"
      ],
      "package_label_principal_display_panel": [
        "Bacitracin Zinc and Polymyxin B Sulfate Label Image"
      ],
      "set_id": "19b4cfab-5927-47c5-a032-58ab2998d9c7",
      "id": "325d8b12-136d-4848-96c5-46c8d0d2702c",
      "effective_time": "20260113",
      "version": "4",
      "openfda": {
        "application_number": [
          "ANDA064046"
        ],
        "brand_name": [
          "Bacitracin Zinc and Polymyxin B Sulfate"
        ],
        "generic_name": [
          "BACITRACIN ZINC AND POLYMYXIN B SULFATE"
        ],
        "manufacturer_name": [
          "A-S Medication Solutions"
        ],
        "product_ndc": [
          "50090-7189"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "BACITRACIN ZINC",
          "POLYMYXIN B SULFATE"
        ],
        "rxcui": [
          "308511"
        ],
        "spl_id": [
          "325d8b12-136d-4848-96c5-46c8d0d2702c"
        ],
        "spl_set_id": [
          "19b4cfab-5927-47c5-a032-58ab2998d9c7"
        ],
        "package_ndc": [
          "50090-7189-0"
        ],
        "original_packager_product_ndc": [
          "24208-555"
        ],
        "unii": [
          "89Y4M234ES",
          "19371312D4"
        ]
      }
    }
  ]
}