{"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. Structure Image 1 Structure Image 2"],"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":"20110826","how_supplied":["HOW SUPPLIED Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP, sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8 oz) with ophthalmic tip. NDC 17478-238-35"],"id":"5295317e-d212-42f5-9bed-add0b7a67362","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":["PACKAGE LABEL - AK - POLY-BAC OPHTHALMIC OINTMENT 3.5 GRAMS 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":"628745db-880e-4663-b064-933f16c47f5c","spl_product_data_elements":["BACITRACIN ZINC AND POLYMYXIN B SULFATE BACITRACIN ZINC AND POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN POLYMYXIN B SULFATE POLYMYXIN B PETROLATUM MINERAL OIL"],"spl_unclassified_section":["Rx only"],"storage_and_handling":["STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured By: Akorn, Inc. Lake Forest, IL 60045 AKP00N Rev. 11/08"],"version":"1","warnings":["WARNINGS Ophthalmic ointments may retard corneal healing."]}