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 July 24, 2019

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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/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/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: Mineral Oil and White Petrolatum.

  • 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.

  • INDICATIONS & 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.

  • ADVERSE REACTIONS


    To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

  • DOSAGE & 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

    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 g tube

    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

    Bausch + Lomb, a division of
    Valeant Pharmaceuticals North America LLC
    Bridgewater, NJ 08807 USA

    © Bausch & Lomb Incorporated

    Revised: November 2017

    9130702 (Folded)
    9130602 (Flat)

  • PRINCIPAL DISPLAY PANEL

    017-35

  • 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:72189-017(NDC:24208-555)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72189-017-353.5 g in 1 BOTTLE; Type 0: Not a Combination Product07/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06404607/24/2019
    Labeler - Direct_Rx (079254320)
    Registrant - Direct_Rx (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    Direct_Rx079254320repack(72189-017)