{"clinical_pharmacology":["CLINICAL PHARMACOLOGY SECTION 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 SECTION This product is contraindicated in those individuals who have shown hypersensitivity to any of its components."],"description":["DESCRIPTION SECTION Polymyxin B Sulfate is the sulfate salt of polymyxin B1 and B2 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. image description image description"],"dosage_and_administration":["DOSAGE & ADMINISTRATION SECTION Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection."],"effective_time":"20200117","how_supplied":["HOW SUPPLIED SECTION 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 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. 11/08 Principal Display Panel Text for Container Label: NDC 17478-238-35 Akorn AK-POLY-BAC™ brand of Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP For Ophthalmic Use Only. Sterile Rx only Net Wt. 3.5 g (1/8oz.)"],"id":"9c59151b-2a6d-a008-e053-2a95a90a70d4","indications_and_usage":["INDICATIONS & USAGE SECTION 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.PRINCIPAL DISPLAY PANEL 989"],"precautions":["PRECAUTIONS SECTION 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":"1df13524-99f3-416c-94f8-4f6e16eb1c7e","spl_product_data_elements":["AK-POLY-BAC AK-POLY-BAC MINERAL OIL PETROLATUM BACITRACIN ZINC BACITRACIN POLYMYXIN B SULFATE POLYMYXIN B"],"version":"4","warnings":["WARNINGS SECTION Ophthalmic ointments may retard corneal healing."]}