BACITRACIN
Rebel Distributors Corp.

BACITRACIN OPHTHALMICOINTMENT USPSTERILE

BACITRACIN- bacitracin ointment 
Rebel Distributors Corp

BACITRACIN
OPHTHALMIC
OINTMENT USP
STERILE

Rx Only

2DESCRIPTION:

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

3ACTION:

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.

4INDICATIONS:

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

5CONTRAINDICATIONS:

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

6PRECAUTIONS:

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.

7ADVERSE 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.

8DOSAGE 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.

9HOW SUPPLIED:

3.5 g (1/8 Oz) sterile tamper proof tubes, NDC 42254-003-35.

Fera logo

Manufactured for:

Fera Pharmaceuticals, LLC
Locust Valley, NY 11560

FPBC00N                   Rev. 08/09

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

11PRINCIPAL DISPLAY PANEL

Bacitracin 500 Units

BACITRACIN 
bacitracin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42254-003(NDC: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  
Packaging
# Item Code Package Description
1 NDC:42254-003-35 1 in 1 CARTON
1 3.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061212 01/11/2010
Labeler - Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Business Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 11/2011
 
Rebel Distributors Corp

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