Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC AND POLYMYXIN B SULFATE BAUSCH & LOMB INCORPORATED FDA Approved 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: 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/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. bacitracinchemstructure polychemstructure
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Substance Bacitracin Zinc
Route
OPHTHALMIC
Applications
ANDA064046
Package NDC

Drug Facts

Composition & Profile

Strengths
3.5 g
Quantities
2023 count
Treats Conditions
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

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
89Y4M234ES 19371312D4
Packaging

HOW SUPPLIED 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 do not use Storage: 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); PRINCIPAL DISPLAY PANEL NDC 24208-555-55 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 carton

Package Descriptions
  • HOW SUPPLIED 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 do not use Storage: 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)
  • PRINCIPAL DISPLAY PANEL NDC 24208-555-55 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 carton

Overview

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: 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/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. bacitracinchemstructure polychemstructure

Indications & 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.

Dosage & 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

Warnings & Precautions
WARNINGS Ophthalmic ointments may retard corneal healing.
Contraindications

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

Adverse Reactions

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.

Storage & Handling

Storage: 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)


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