AK-POLY-BAC- bacitracin zinc and polymyxin b sulfate ointment
A-S Medication Solutions LLC

Rx only


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:

Structural Formula
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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:

Structural Formula
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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.


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.


For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.


This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.


Ophthalmic ointments may retard corneal healing.


As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.


Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.


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 17478-238-35


Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured By: Akorn, Inc.
Lake Forest, IL 60045
Rev. 11/08

NDC 54569-3570-0

Relabeled by:
A-S Medication Solutions
Libertyville, IL 60048

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bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-3570(NDC:17478-238)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bacitracin Zinc (Bacitracin) Bacitracin 500 [USP'U] in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B 10000 [USP'U] in 1 g
Inactive Ingredients
Ingredient Name Strength
Mineral Oil
# Item Code Package Description Multilevel Packaging
1 NDC:54569-3570-0 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 3.5 g in 1 TUBE This package is contained within the CARTON (54569-3570-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064028 05/08/2006
Labeler — A-S Medication Solutions LLC (830016429)
Name Address ID/FEI Operations
A-S Medication Solutions LLC 830016429 relabel (54569-3570)

Revised: 10/2013 A-S Medication Solutions LLC

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