Label: AK-POLY-BAC- bacitracin zinc and polymyxin b sulfate ointment

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 18, 2018

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  • SPL UNCLASSIFIED SECTION

    Rx only

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  • 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:

    Structural Formula

    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:

    Structural Formula

    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.

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  • 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.

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  • 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.

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  • CONTRAINDICATIONS:

    This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

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  • WARNINGS:

    Ophthalmic ointments may retard corneal healing.

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  • 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.

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  • DOSAGE AND ADMINISTRATION:

    Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

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  • 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 17478-238-35

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  • STORAGE:

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

    Akorn
    Manufactured By: Akorn, Inc.
    Lake Forest, IL 60045
    AKP00N
    Rev. 06/16

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-238-35 Akorn

    AK-POLY-BACâ„¢

    brand of Bacitracin Zinc and Polymyxin B Sulfate

    Ophthalmic Ointment USP

    For Ophthalmic Use Only. Sterile

    Rx only Net Wt 3.5 g (1/8 oz)

    Principal Display Panel Text for Container Label
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 17478-238-35

    AK-POLY-BACâ„¢

    brand of Bacitracin Zinc and Polymyxin B Sulfate

    Ophthalmic Ointment, USP

    Net Wt 3.5 g (1/8 oz.) Sterile Rx only Akorn Logo

    Principal Display Panel Text for Carton Label
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  • INGREDIENTS AND APPEARANCE
    AK-POLY-BAC 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-238
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 500 [USP'U]  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B 10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Mineral Oil (UNII: T5L8T28FGP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17478-238-35 1 in 1 CARTON 05/08/2006
    1 3.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA064028 05/08/2006
    Labeler - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 603980319 MANUFACTURE(17478-238) , ANALYSIS(17478-238) , STERILIZE(17478-238) , PACK(17478-238) , LABEL(17478-238)
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