{"clinical_pharmacology":["CLINICAL PHARMACOLOGY: Polymyxin B attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and H influenzae species. Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci."],"contraindications":["CONTRAINDICATIONS: This product is contraindicated in those individuals who have shown hypersensitivity to any of its components."],"description":["DESCRIPTION: Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is a sterile antimicrobial ointment 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 per 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 per mg, calculated on an anhydrous basis. The structural formulae are: Each gram contains: Bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, white petrolatum and mineral oil. Structural Formula Structural Formula"],"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."],"effective_time":"20171219","how_supplied":["HOW SUPPLIED: Product: 50090-0447 NDC: 50090-0447-0 3.5 g in a TUBE"],"id":"71f22077-b18d-4d51-871c-e0c69f44fc3b","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."],"openfda":{},"package_label_principal_display_panel":["Bacitracin Zinc and Polymyxin B Sulfate Label Image"],"precautions":["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."],"set_id":"9d7a5fb6-ad90-43e2-9734-d165ab19da73","spl_product_data_elements":["AK-POLY-BAC Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC BACITRACIN POLYMYXIN B SULFATE POLYMYXIN B Mineral Oil Petrolatum"],"spl_unclassified_section":["Rx only"],"storage_and_handling":["STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Akorn Manufactured By: Akorn, Inc. Lake Forest, IL 60045 AKP00N Rev. 06/16"],"version":"9","warnings":["WARNINGS: Ophthalmic ointments may retard corneal healing."]}