BACITRACIN - bacitracin ointment 
E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.

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Rx Only

DESCRIPTION:

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

ACTION:

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

INDICATIONS:

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.

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:

3.5 g (1/8 Oz.) sterile tamper proof tubes, NDC 0168-0026-38.

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747

I22638D

R10/07

#247

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 3.5 gram CARTON

NDC 0168-0026-38

Fougera®

Rx only

BACITRACIN OPHTHALMIC

OINTMENT USP

STERILE

CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil.

NET WT 3.5 g (1/8 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 3.5g CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 3.5 gram Label

NDC 0168-0026-38

Fougera®

BACITRACIN OPHTHALMIC

OINTMENT USP

STERILE

Rx only

CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil.

NET WT 3.5 g (1/8 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 3.5g Label

BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0168-0026
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (BACITRACIN) BACITRACIN500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0168-0026-381 TUBE in 1 CARTONcontains a TUBE
13.5 g in 1 TUBEThis package is contained within the CARTON (0168-0026-38)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06121211/09/197107/31/2009

Labeler - E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. (043838424)
Establishment
NameAddressID/FEIOperations
Fougera Pharmaceuticals Inc.174491316MANUFACTURE
Establishment
NameAddressID/FEIOperations
Fougera Pharmaceuticals Inc.043838424ANALYSIS

Revised: 11/2012 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.