Label: AK-POLY-BAC- ak-poly-bac ointment

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

Drug Label Information

Updated November 10, 2016

If you are a consumer or patient please visit this version.

  • DESCRIPTION SECTION

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    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:

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    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 SECTION

    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 & USAGE SECTION

    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 SECTION

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

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  • WARNINGS SECTION

    Ophthalmic ointments may retard corneal healing.

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  • PRECAUTIONS SECTION

    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 & ADMINISTRATION SECTION

    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 SECTION

    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

    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. 11/08

    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 (1/8oz.)

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    AK-POLY-BAC 
    ak-poly-bac ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-989(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:61919-989-35 3.5 g in 1 CARTON; Type 0: Not a Combination Product 01/01/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA064028 01/01/2014
    Labeler - DIRECT RX (079254320)
    Establishment
    Name Address ID/FEI Business Operations
    DIRECT RX 079254320 relabel(61919-989)
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