Bacitracin and Polymyxin B (Polycin) Package Insert

Prescribing information (package insert) - Bacitracin and Polymyxin B

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 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.

CLINICAL PHARMACOLOGY

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.

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.

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.

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

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

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

Revised: January 2023

9130705 (Folded)

9130605 (Flat)

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 064046 · View the label on DailyMed

Revision date stated in the text: January 2023

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Drug information for Bacitracin and Polymyxin B

Rx or OTC

Prescription (Rx)?

This drug is available only with a prescription from a licensed healthcare provider.
Rx

Drug class

Polymyxin-class Antibacterial

Active ingredients

Bacitracin zinc 500 USP units/g, Polymyxin b sulfate 10000 USP units/g

Dosage form

Ointment

Route

Ophthalmic

Marketing status

listed in the FDA NDC Directory

Company (applicant)

BAUSCH AND LOMB INC

FDA approval

ANDA 064046Abbreviated New Drug Application (ANDA) – generic drug Approved January 26, 1995

Manufacturers

3 labelers list this drug on DailyMed

Packages (NDC)

Package
500 USP units/g, 10000 USP units/g – 3.5 g in 1 tube / 1 in 1 carton NDC 24208-555-55

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.