Other
Rx only
Bacitracin Zinc And Polymyxin B Sulfate
FDA Label NDC 53002-9271
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rpk Pharmaceuticals, Inc. for the product Bacitracin Zinc And Polymyxin B Sulfate (NDC 53002-9271). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, description, clinical pharmacology, indlcatlons and usage, contraindications, warnings, precautions, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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) (5cfad642 E7d0 4451 8bd4 29665208ac8d 01)
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) (5cfad642 E7d0 4451 8bd4 29665208ac8d 02)
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.
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.
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.
Contraindications
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Warnings
Ophthalmic ointments may retard corneal healing.
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.
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.
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
How Supplied
Product: 53002-9271
NDC: 53002-9271-1 3.5 g in a BOTTLE, DROPPER
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