{"adverse_reactions":["ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 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. bacitracinchemstructure polychemstructure"],"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":"20241018","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: NDC 24208-555-55 - 3.5 g tube do not use Storage: Store between 15°C to 25°C (59°F to 77°F). KEEP TIGHTLY CLOSED. KEEP OUT OF REACH OF CHILDREN. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: January 2023 9130705 (Folded) 9130605 (Flat)"],"id":"24c33b97-e464-feca-e063-6394a90ad7d9","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":{"application_number":["ANDA064046"],"brand_name":["Bacitracin Zinc and Polymyxin B Sulfate"],"generic_name":["BACITRACIN ZINC AND POLYMYXIN B SULFATE"],"is_original_packager":[true],"manufacturer_name":["Bausch & Lomb Incorporated"],"package_ndc":["24208-555-55"],"product_ndc":["24208-555"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["OPHTHALMIC"],"rxcui":["308511"],"spl_id":["24c33b97-e464-feca-e063-6394a90ad7d9"],"spl_set_id":["1b317249-30eb-4415-8a1c-cfedb4ba3549"],"substance_name":["BACITRACIN ZINC","POLYMYXIN B SULFATE"],"unii":["89Y4M234ES","19371312D4"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 24208-555-55 Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP (Sterile) FOR OPHTHALMIC USE ONLY Rx only Net Wt. 3.5 g (1/8 oz) BAUSCH + LOMB 9733303 AB07534 carton"],"set_id":"1b317249-30eb-4415-8a1c-cfedb4ba3549","spl_product_data_elements":["Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate PETROLATUM MINERAL OIL BACITRACIN ZINC BACITRACIN POLYMYXIN B SULFATE POLYMYXIN B"],"spl_unclassified_section":["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°C to 25°C (59°F to 77°F). KEEP TIGHTLY CLOSED. KEEP OUT OF REACH OF CHILDREN. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: January 2023 9130705 (Folded) 9130605 (Flat)"],"version":"11","warnings":["WARNINGS Ophthalmic ointments may retard corneal healing."]}