Bacitracin

Pronunciation

Dosage Form: ophthalmic ointment

Bacitracin Ophthalmic Ointment USP

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.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

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 0574-4022-13 3 – 1 g sterile tamper evident tubes with ophthalmic tip.

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].

Manufactured For

Perrigo®

Minneapolis, MN 55427

0S400 RC J1

Rev 08-13 A

R0813

Ini0813

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Carton (Sample Only)

Rx Only

NDC 0574-4022-01

Bacitracin Ophthalmic Ointment USP

FOR USE IN THE EYES ONLY

NET WT 1 g

STERILE

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Label

Rx Only

NDC 0574-4022-11

Bacitracin Ophthalmic Ointment, USP 500 units/g

FOR USE IN THE EYES ONLY

NET WT 1 g

STERILE

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3 – 1 g Tube Carton

Rx Only

NDC 0574-4022-13

Bacitracin Ophthalmic Ointment USP, 500 units/g

3 – 1 g tubes

Sterile Ophthalmic Ointment

FOR USE IN THE EYES ONLY

Weighing 1 gram each

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Label

Rx Only

NDC 0574-4022-11

Bacitracin Ophthalmic Ointment, USP 500 units/g

FOR USE IN THE EYES ONLY

NET WT 1 g

STERILE

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3.5 g Label

Rx Only

NDC 0574-4022-35

Bacitracin Ophthalmic Ointment USP

NET WT 3.5 g (1/8 oz)

STERILE

Bacitracin 
Bacitracin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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
1 NDC:0574-4022-01 1 TUBE in 1 CARTON
1 NDC:0574-4022-11 1 g in 1 TUBE
2 NDC:0574-4022-13 3 TUBE in 1 CARTON
2 NDC:0574-4022-11 1 g in 1 TUBE
3 NDC:0574-4022-35 1 TUBE in 1 CARTON
3 3.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061212 03/10/2014
Labeler - Paddock Laboratories, LLC (967694121)
Revised: 12/2013
 
Paddock Laboratories, LLC



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