Prescription Drug Information: Bacitracin

BACITRACIN- bacitracin ointment
Padagis US LLC

STERILE Rx Only

DESCRIPTION:

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

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 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:

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.

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 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

carton
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BACITRACIN
bacitracin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-4022
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN) BACITRACIN 500 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0574-4022-01 1 TUBE in 1 CARTON contains a TUBE (0574-4022-11)
1 NDC:0574-4022-11 1 g in 1 TUBE This package is contained within the CARTON (0574-4022-01)
2 NDC:0574-4022-13 3 TUBE in 1 CARTON contains a TUBE (0574-4022-11)
2 NDC:0574-4022-11 1 g in 1 TUBE This package is contained within the CARTON (0574-4022-13)
3 NDC:0574-4022-35 1 TUBE in 1 CARTON contains a TUBE
3 3.5 g in 1 TUBE This package is contained within the CARTON (0574-4022-35)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061212 03/10/2014
Labeler — Padagis US LLC (967694121)

Revised: 11/2022 Padagis US LLC

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