Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP (Sterile)

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SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION:

DESCRIPTION SECTION

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:

CLINICAL PHARMACOLOGY SECTION

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.

INDlCATlONS AND USAGE:

INDICATIONS & USAGE SECTION

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:

CONTRAINDICATIONS SECTION

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

WARNINGS:

WARNINGS SECTION

Ophthalmic ointments may retard corneal healing.

PRECAUTIONS:

SPL UNCLASSIFIED SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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:

HOW SUPPLIED SECTION

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 - NDC 42254-154-35

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

Storage:

STORAGE AND HANDLING SECTION

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

KEEP OUT OF REACH OF CHILDREN.

Revised November 2007

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

9130700 (Folded)
9130600 (Flat)

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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• Bacitracin Zinc and Polymyxin B Sulfate
• BACITRACIN ZINC
• BACITRACIN
• POLYMYXIN B SULFATE
• POLYMYXIN B
• PETROLATUM
• MINERAL OIL

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