{"adverse_reactions":["To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch"],"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."],"contraindications":["This product is contraindicated in those individuals who have shown hypersensitivity to any of its components."],"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: [Bacitracin A (Strucural Formula)] 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/mg, calculated on an anhydrous basis. The structural formulae are: [Polymyxin B Sulfate (Structural Formula)] 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."],"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"],"effective_time":"20190724","how_supplied":["HOW SUPPLIED Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP is available in tubes with an ophthalmic tip applicator in the following size: 3.5 g tube DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. Storage Store between 15°-25°C (59°-77°F). KEEP TIGHTLY CLOSED. Keep out of reach of children Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA © Bausch & Lomb Incorporated Revised: November 2017 9130702 (Folded) 9130602 (Flat)"],"id":"8e6c9fb6-c8dc-20db-e053-2a95a90a3a86","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":["017-35"],"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":"8e6c9fb6-c8db-20db-e053-2a95a90a3a86","spl_product_data_elements":["BACITRACIN ZINC AND POLYMYXIN B SULFATE BACITRACIN ZINC AND POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN PETROLATUM POLYMYXIN B SULFATE POLYMYXIN B MINERAL OIL"],"spl_unclassified_section":["Rx only"],"version":"1","warnings":["Ophthalmic ointments may retard corneal healing."]}