Drugplain

Bacitracin Zinc and Polymyxin B Sulfate 500 [USP'U]/g

Bacitracin Zinc and Polymyxin B Sulfate · OINTMENT · Bausch & Lomb Incorporated

2 Recalls on Record
Plain English

This is a prescription antibiotic ointment applied to the eye that contains bacitracin and polymyxin B, two antibiotics used to prevent or treat bacterial eye infections. It is typically used for minor cuts, scrapes, or infections of the eye surface.

Key Facts

Brand Name
Bacitracin Zinc and Polymyxin B Sulfate
Generic Name
Bacitracin Zinc and Polymyxin B Sulfate
NDC Code (Product)
24208-555
Manufacturer
Bausch & Lomb Incorporated
Strength
500 [USP'U]/g
Dosage Form
OINTMENT
Route
OPHTHALMIC
Marketing Status
Application #
ANDA064046
Marketing Start
04/25/2008

Recall History

2 Recalls on Record
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

headache12 reports
off label use12 reports
weight increased12 reports
pain11 reports
pruritus11 reports
wheezing11 reports
dyspepsia10 reports
hypersensitivity10 reports
rash10 reports
weight decreased10 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

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

Warnings

WARNINGS Ophthalmic ointments may retard corneal healing.

Contraindications

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

Adverse Reactions

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.

Frequently Asked Questions

What is Bacitracin Zinc and Polymyxin B Sulfate used for?

This is a prescription antibiotic ointment applied to the eye that contains bacitracin and polymyxin B, two antibiotics used to prevent or treat bacterial eye infections. It is typically used for minor cuts, scrapes, or infections of the eye surface.

Is Bacitracin Zinc and Polymyxin B Sulfate a controlled substance?

Bacitracin Zinc and Polymyxin B Sulfate is not classified as a controlled substance by the DEA.

What is the generic name for Bacitracin Zinc and Polymyxin B Sulfate?

The generic name for Bacitracin Zinc and Polymyxin B Sulfate is Bacitracin Zinc and Polymyxin B Sulfate. There are 8 other brand versions of Bacitracin Zinc and Polymyxin B Sulfate.

What is the NDC code for Bacitracin Zinc and Polymyxin B Sulfate 500 [USP'U]/g?

The NDC (National Drug Code) for Bacitracin Zinc and Polymyxin B Sulfate 500 [USP'U]/g is 24208-555, listed by Bausch & Lomb Incorporated.

Product NDC

24208-555

Package NDC

24208-555-55

Other Bacitracin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)