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 48102-007-35.

Fera logo

Manufactured for:

Fera Pharmaceuticals, LLC
Locust Valley, NY 11560

FPBC00N Rev. 08/09

PRINCIPAL DISPLAY PANEL - Carton Label

NDC 48102-007-35

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)

USUAL DOSAGE: 3 applications daily.
See insert for complete information.

KEEP TIGHTLY CLOSED
STORE AT ROOM TEMPERATURE
KEEP OUT OF REACH OF CHILDREN

See crimp of tube for Lot No. & Exp. Date

PRINCIPAL DISPLAY PANEL - Container Label

NDC 48102-007-35

BACITRACIN
OPHTHALMIC
OINTMENT USP
STERILE

Rx only

USUAL DOSAGE: 3 applications daily.
See insert for complete information.

WARNING: Keep out of reach of children.

See crimp for Lot No. and Exp. Date

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

NET WT 3.5 g (1/8 Oz)

KEEP TIGHTLY CLOSED
STORE AT ROOM TEMPERATURE

BACITRACIN
bacitracin ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	48102-007
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN (BACITRACIN)	BACITRACIN	500 [iU] in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL
PETROLATUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	48102-007-35	1 TUBE In 1 CARTON	contains a TUBE
1		3.5 g In 1 TUBE	This package is contained within the CARTON (48102-007-35)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA061212	01/11/2010

Labeler - Fera Pharmaceuticals (831023713)

Revised: 08/2009Fera Pharmaceuticals