Bacitracin Zinc and Polymyxin B Sulfate

Overview

Brand name

Bacitracin Zinc and Polymyxin B Sulfate

Generic name

Bacitracin Zinc and Polymyxin B Sulfate

Dosage form

Ointment

Route

Ophthalmic

Marketing category

ANDA · ANDA

Labeler

A-S Medication Solutions

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

4

Packages

4

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Bacitracin Zinc	500 [USP'U]/g	204602	View
Polymyxin B Sulfate	10000 [USP'U]/g	204602	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Ointment

Route of administration

Ophthalmic

Presentations

8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Decreased Cell Wall Synthesis & Repair [PE]	PE	All 41 members
Polymyxin-class Antibacterial [EPC]	EPC	All 55 members
Polymyxins [CS]	CS	All 55 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

064046

Application type

ANDA · Abbreviated New Drug Application

Approval date

January 26, 1995

Sponsor

BAUSCH AND LOMB INC

Products on application

1

Submissions recorded

12

Products approved under application 064046.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
064046-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	OINTMENT		BACITRACIN ZINC; POLYMYXIN B SULFATE	Prescription	AT	RS

Therapeutic equivalence

Source: Orange Book

TE code

AT

Reference Listed Drug

No

Reference Standard

Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (topical dermatological products)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 064046.
Type	No.	Action	Status	Date	Review
Supplement	11	Manufacturing (CMC)	Approved	August 5, 2002	—
Supplement	10	Manufacturing (CMC)	Approved	November 27, 2001	—
Supplement	9	Manufacturing (CMC)	Approved	March 7, 2001	—
Supplement	8	Manufacturing (CMC)	Approved	June 27, 2000	—
Supplement	7	Manufacturing (CMC)	Approved	April 28, 2000	—
Supplement	6	Manufacturing (CMC)	Approved	June 7, 1999	—
Supplement	5	Manufacturing (CMC)	Approved	May 26, 1999	—
Supplement	4	Manufacturing (CMC)	Approved	October 22, 1998	—
Supplement	3	Manufacturing (CMC)	Approved	May 4, 1998	—
Supplement	2	Manufacturing (CMC)	Approved	June 20, 1996	—
Supplement	1	Manufacturing (CMC)	Approved	January 31, 1996	—
Original application	1		Approved	January 26, 1995	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260113). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20260113 HUMAN PRESCRIPTION DRUG · 20241230

Indications and Usage

openFDA Drug Labeling

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.

Dosage and Administration

openFDA Drug Labeling

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

Contraindications

openFDA Drug Labeling

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

Warnings

openFDA Drug Labeling

WARNINGS Ophthalmic ointments may retard corneal healing.

Adverse Reactions

openFDA Drug Labeling

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.

Description

openFDA Drug Labeling

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 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. Bacitracin A (Strucural Formula) Polymyxin B Sulfate (Structural Formula)

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP is available in tubes with an ophthalmic tip applicator in the following size: tube of 3.5g -NDC 68071-5267-3 Storage Store between 15° to 25°C (59° to 77°F). KEEP TIGHTLY CLOSED Keep out of reach of children. Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2020 Bausch & Lomb Incorporated or its affiliates Revised: February 2020 9130703 (Folded) 9130603 (Flat)

Adverse event reports

Source: openFDA FAERS

4,875

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: POLYMYXIN B SULFATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
50090-3274-0	50090-3274	A-S Medication Solutions	1 TUBE in 1 CARTON (50090-3274-0) / 3.5 g in 1 TUBE	November 21, 2017
50090-7189-0	50090-7189	A-S Medication Solutions	144 TUBE in 1 CASE (50090-7189-0) / 3.5 g in 1 TUBE	July 2, 2024
24208-555-55	24208-555	Bausch & Lomb Incorporated	1 TUBE in 1 CARTON (24208-555-55) / 3.5 g in 1 TUBE	April 25, 2008
68071-5267-3	68071-5267	NuCare Pharmaceuticals,Inc.	3.5 g in 1 BOX (68071-5267-3)	June 3, 2020
50090-3274	50090-3274	A-S Medication Solutions	—	April 25, 2008
50090-7189	50090-7189	A-S Medication Solutions	—	April 25, 2008
24208-555	24208-555	Bausch & Lomb Incorporated	—	April 25, 2008
68071-5267	68071-5267	NuCare Pharmaceuticals,Inc.	—	April 25, 2008

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.