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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. INDICATIONS AND USAGE
    5. CONTRAINDICATIONS
    6. WARNINGS
    7. PRECAUTIONS
    8. DOSAGE AND ADMINISTRATION
    9. HOW SUPPLIED
    10. STORAGE
    11. PRINCIPAL DISPLAY PANEL

Bacitracin Zinc And Polymyxin B Sulfate Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. 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 is a sterile antimicrobial ointment 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: Bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, white petrolatum and mineral oil.


Clinical Pharmacology



Polymyxin B attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and H 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 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.


How Supplied



Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP, sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8 oz) with ophthalmic tip.

NDC 54868-1199-0


Storage



Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured By: Akorn, Inc.
Lake Forest, IL 60045

AKP00N
Rev. 11/08



Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK      74146

Principal Display Panel



Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP

3.5 g (1/8 ounce)

image of package label - 1199

image of package label - 1199


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