Bacitracin Zinc And Polymyxin B Sulfate

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

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

FOR OPHTHALMIC USE ONLY

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

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.

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

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 subtilisvar 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 ₁and 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.

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)

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.

Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosaand Haemophilus influenzaespecies.

Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.

NDC24208-555-55

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

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)

Ophthalmic ointments may retard corneal healing.

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 subtilisvar 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 ₁and 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.

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

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

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.

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

Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosaand Haemophilus influenzaespecies.

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.

NDC24208-555-55

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

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

FOR OPHTHALMIC USE ONLY