BACITRACIN- bacitracin ointment 
Akorn, Inc.

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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.

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 Container Label

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

Principal Display Panel Text for Carton Label
BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:17478-708
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin (Bacitracin) Bacitracin500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Petrolatum 
Mineral Oil 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-708-351 in 1 CARTON
13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20325712/13/201302/25/2014
Labeler - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc603980319MANUFACTURE(17478-708), ANALYSIS(17478-708), STERILIZE(17478-708), PACK(17478-708), LABEL(17478-708)

Revised: 12/2013
 
Akorn, Inc.