Bacitracin Polymyxin B

Generic Name: bacitracin zinc and polymyxin B sulfate
Dosage Form: ophthalmic ointment

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

Rx only

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.

INDlCATlONS 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:

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.

Storage:

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)

PRINCIPAL DISPLAY PANEL

NDC 24208-555-55

Bausch & Lomb

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

Rx only

[icon- eye] [icon- ointment] [icon- 3.5 gm]

Net wt. 1/8 oz (3.5g)

BACITRACIN ZINC AND POLYMYXIN B SULFATE
bacitracin zinc and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	24208-555
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (BACITRACIN)	BACITRACIN ZINC	500 in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B)	POLYMYXIN B SULFATE	10000 in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM
MINERAL OIL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	24208-555-55	1 TUBE In 1 CARTON	contains a TUBE
1		3.5 g In 1 TUBE	This package is contained within the CARTON (24208-555-55)