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 llchenlformis 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 B ₁ and B ₂ 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 conjunctive 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:   As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible orgamisms, 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 sizes:

3.5 gram tube--NDC# 61570-049-35

Storage:

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

KEEP OUT OF REACH OF CHILDREN.

Rx only

Mfg. for. Monarch Pharmaceuticals, Inc., Bristol, TN 37620

XO51008 R.5/99-9E

By: Bausch & Lomb Pharmaceuticals, Inc, Tampa, FL 33637

GTD7534