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  5. Label Information: Bacitracin Zinc And Polymyxin B Sulfate

FDA Label for Bacitracin Zinc And Polymyxin B Sulfate

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. DESCRIPTION:
    3. CLINICAL PHARMACOLOGY:
    4. INDLCATLONS AND USAGE:
    5. CONTRAINDICATIONS:
    6. WARNINGS:
    7. PRECAUTIONS:
    8. DOSAGE AND ADMINISTRATION:
    9. HOW SUPPLIED:
    10. STORAGE:

Bacitracin Zinc And Polymyxin B Sulfate Product Label

The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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:

Bacitracin A (Strucural Formula) - c6c69fa4 d7be 4c09 b7fa 53c40fad78a7 01

Bacitracin A (Strucural Formula) - c6c69fa4 d7be 4c09 b7fa 53c40fad78a7 01

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 - NDC 42254-154-35

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)

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320


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