Bacitracin Polymyxin B

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)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA064046	04/25/2008

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		807927397	MANUFACTURE

Revised: 02/2011Bausch & Lomb Incorporated

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