{"adverse_reactions":["ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"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."],"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, 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. Bacitracin A (Strucural Formula) Polymyxin B Sulfate (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. FOR OPHTHALMIC USE ONLY"],"effective_time":"20241230","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: tube of 3.5g -NDC 68071-5267-3 Storage Store between 15° to 25°C (59° to 77°F). KEEP TIGHTLY CLOSED Keep out of reach of children. Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2020 Bausch & Lomb Incorporated or its affiliates Revised: February 2020 9130703 (Folded) 9130603 (Flat)"],"id":"2a849ae9-3395-4642-e063-6394a90a1ca4","indications_and_usage":["INDlCATlONS 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":{"application_number":["ANDA064046"],"brand_name":["Bacitracin Zinc and Polymyxin B Sulfate"],"generic_name":["BACITRACIN ZINC AND POLYMYXIN B SULFATE"],"manufacturer_name":["NuCare Pharmaceuticals,Inc."],"original_packager_product_ndc":["24208-555"],"package_ndc":["68071-5267-3"],"product_ndc":["68071-5267"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["OPHTHALMIC"],"rxcui":["308511"],"spl_id":["2a849ae9-3395-4642-e063-6394a90a1ca4"],"spl_set_id":["a73654f4-949d-3da4-e053-2995a90a1fc3"],"substance_name":["BACITRACIN ZINC","POLYMYXIN B SULFATE"],"unii":["89Y4M234ES","19371312D4"],"upc":["0368071526738"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL pdp"],"set_id":"a73654f4-949d-3da4-e053-2995a90a1fc3","spl_product_data_elements":["Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate MINERAL OIL BACITRACIN ZINC BACITRACIN POLYMYXIN B SULFATE POLYMYXIN B PETROLATUM"],"spl_unclassified_section":["Rx only","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."],"storage_and_handling":["Storage Store between 15° to 25°C (59° to 77°F). KEEP TIGHTLY CLOSED Keep out of reach of children. Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2020 Bausch & Lomb Incorporated or its affiliates Revised: February 2020 9130703 (Folded) 9130603 (Flat)"],"version":"6","warnings":["WARNINGS Ophthalmic ointments may retard corneal healing."]}