Bacitracin

Pronunciation

Dosage Form: ophthalmic ointment

Bacitracin
Ophthalmic
Ointment USP

Rx only

DESCRIPTION:

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

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CLINICAL PHARMACOLOGY:

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 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.

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 17478-708-35.

STORAGE:

Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]

AKORN

Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

BC00N
Rev. 07/12

Principal Display Panel Text for Container Label:

NDC 17478-708-35

Bacitracin Ophthalmic

Ointment, USP

R x only Net Wt. 3.5 g (1/8 oz)

Principal Display Panel Text for Carton Label:

NDC 17478-708-35

Bacitracin Ophthalmic

Ointment, USP

Sterile

Rx only Net Wt 3.5 g (1/8 oz.) Akorn logo

Bacitracin 
Bacitracin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-708
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:17478-708-35 1 TUBE 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 ANDA203257 12/13/2013
Labeler - Akorn, Inc. (062649876)
Establishment
Name Address ID/FEI Operations
Akorn, Inc 603980319 MANUFACTURE(17478-708), ANALYSIS(17478-708), STERILIZE(17478-708), PACK(17478-708), LABEL(17478-708)
Revised: 12/2013
 
Akorn, Inc.



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