bacitracin zinc and polymyxin b sulfate (Bacitracin Zinc and Polymyxin B Sulfate)  ointment 
[Bausch & Lomb Incorporated]

Description

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP is a sterile antimicrobial ointment formulated for ophthalmic use.

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula for bacitracin A is:

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:

Each Gram Contains: ACTIVES: Bacitracin Zinc equal to 500 bacitracin units and Polymyxin B Sulfate equal to 10,000 polymyxin B units; INACTIVES: White Petrolatum and Mineral Oil.

Clinical Pharmacology

Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and Haemophilus influenzae species.

Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.

Indications and Usage

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.

Contraindications

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Warnings

Ophthalmic ointments may retard corneal healing.

Precautions

General

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.

Dosage and Administration

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

FOR OPHTHALMIC USE ONLY.

How Supplied

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP is available in tubes with an ophthalmic tip applicator in the following size:

3.5 gram tube - Prod. No. 07534

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

STERILE OPHTHALMIC OINTMENT

Rx only

Storage Conditions

Store between 15°-25°C (59°-77°F). KEEP TIGHTLY CLOSED.

KEEP OUT OF REACH OF CHILDREN.

Manufacturing Information

Bausch & Lomb Incorporated

Tampa, FL 33637

©Bausch & Lomb Incorporated

X051026 (Folded)

XM10096 (Flat)

R.12/03-02

Bacitracin Zinc and Polymyxin B Sulfate (Bacitracin Zinc and Polymyxin B Sulfate)

PRODUCT INFO Product Code 24208-555 Dosage Form OINTMENT Route Of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Bacitracin Zinc (BACITRACIN) Active 500 UNITS  In 1 GRAM Polymyxin B Sulfate (POLYMYXIN B) Active 10000 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 24208-555-55 1 TUBE In 1 CARTON contains a TUBE 1 3.5 GRAM In 1 TUBE This package is contained within the CARTON (24208-555-55)

Revised: 04/2008Bausch & Lomb Incorporated