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BACITRACIN Label and BACITRACIN General Information

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bacitracin (Bacitracin)  ointment 
[E. FOUGERA and CO.]

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 Altana Inc.
MELVILLE, NEW YORK 11747

I22638C
#247
R3/98

Bacitracin (Bacitracin)

PRODUCT INFO Product Code 0168-0026 Dosage Form OINTMENT Route Of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Bacitracin (Bacitracin) Active 500 UNITS  In 1 GRAM white petrolatum Inactive   mineral oil Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size

PACKAGING # NDC Package Description Multilevel Packaging 1 0168-0026-38 3.5 GRAM In 1 TUBE None

Revised: 12/2006