Bacitracin: Package Insert / Prescribing Info

Bacitracin Description

Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.

Bacitracin - Clinical Pharmacology

The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphlococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi.

Indications and Usage for Bacitracin

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.

Contraindications

This product should not be used in patients with a history of hypersensitivity to Bacitracin.

Precautions

Bacitracin ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted.

Adverse Reactions/Side Effects

Bacitracin has such a low incidence of allergenicity that for all practical purposes side reactions are practically non-existent. However, if such reaction should occur, therapy should be discontinued.

To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Bacitracin Dosage and Administration

The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.

How is Bacitracin supplied

NDC 0574-4022-35 3.5 g (1/8 oz.) sterile tamper evident tubes with ophthalmic tip.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Made in Canada

Manufactured by Jubilant HollisterStier General Partnership
Kirkland, Quebec H9H 4J4 Canada

Distributed By Perrigo, Allegan, MI 49010

Minneapolis, MN 55427

35F00 RC J1

Rev 08-21

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3.5 g Carton

Rx Only

NDC 0574-4022-35

Bacitracin Ophthalmic Ointment USP

NET WT 3.5 g (1/8 oz)

STERILE

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