Other
Rx only
Manufactured By: Akorn, Inc.
Lake Forest, IL 60045
Repackaged by:
Rebel Distributors Corp.
Thousand Oaks, CA 91320
Bacitracin Zinc And Polymyxin B Sulfate
FDA Label NDC 21695-156
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp. for the product Bacitracin Zinc And Polymyxin B Sulfate (NDC 21695-156). 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, indications and usage, contraindications, warnings, precautions, dosage and administration, 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 is a sterile antimicrobial ointment 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:
Chemical Structure (Dc47903e 8d29 43eb A647 1e8d28232bb9 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 per mg, calculated on an anhydrous basis. The structural formulae are:
Chemical Structure (Dc47903e 8d29 43eb A647 1e8d28232bb9 02)
Each gram contains: Bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, white petrolatum and mineral oil.
Clinical Pharmacology
Polymyxin B attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and H influenzae species.
Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.
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.
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.
Dosage And Administration
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
How Supplied
Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP, sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8 oz) with ophthalmic tip.
NDC 21695-156-35
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Principal Display Panel
Bacitracin Zinc/polymyxin B 500/10,000 Units (Dc47903e 8d29 43eb A647 1e8d28232bb9 03)
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