{"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 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: ACTIVES: Bacitracin Zinc equal to 500 bacitracin units and Polymyxin B Sulfate equal to 10,000 polymyxin B units; INACTIVES: White Petrolatum and Mineral Oil. 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":"20120216","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 gram tube - NDC 42254-154-35 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. Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9130700 (Folded) 9130600 (Flat) Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320"],"id":"c6c69fa4-d7be-4c09-b7fa-53c40fad78a7","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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Bacitracin Zinc/Polymyxin B 500/10,000 Units"],"set_id":"c6c69fa4-d7be-4c09-b7fa-53c40fad78a7","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","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°-25°C (59°-77°F). KEEP TIGHTLY CLOSED. KEEP OUT OF REACH OF CHILDREN. Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9130700 (Folded) 9130600 (Flat) Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320"],"version":"1","warnings":["WARNINGS: Ophthalmic ointments may retard corneal healing."]}