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Bacitracin Zinc and Polymyxin B Sulfate (Bausch & Lomb Incorporated)

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OINTMENT 1 TUBE in 1 CARTON (24208-555-55) > 3.5 g in 1 TUBE Label Information

Complete Bacitracin Zinc and Polymyxin B Sulfate Information

  • 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.


  • 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.


  • 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 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 g tube (NDC 24208-555-55)

    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

    NDC 24208-555-55

    Bacitracin Zinc and
    Polymyxin B Sulfate
    Ophthalmic
    Ointment, USP
    (Sterile)
    FOR OPHTHALMIC USE ONLY

    Rx only

    Net Wt. 1/8 oz
    (3.5 g)

    BAUSCH + LOMB

    carton.jpg

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC AND POLYMYXIN B SULFATE 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-555
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24208-555-55 1 in 1 CARTON 04/25/2008
    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 ANDA064046 04/25/2008
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-555)