Label: 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 February 16, 2012

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  • SPL UNCLASSIFIED SECTION

    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)

    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:

    Polymyxin B Sulfate (Structural Formula)

    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

  • PRINCIPAL DISPLAY PANEL

    Bacitracin Zinc/Polymyxin B 500/10,000 Units

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC AND POLYMYXIN B SULFATE 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42254-154(NDC:24208-555)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500   in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE10000   in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42254-154-351 in 1 CARTON
    13.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06404604/25/2008
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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