Label: BACITRACIN ZINC AND POLYMYXIN B SULFATE ointment

  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated June 6, 2023

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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 B 1 and B 2, 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 Incorporated 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:

    Box of 3.5g NDC 68071-5267-3

    Storage

    Store between 15° to 25°C (59° to 77°F). KEEP TIGHTLY CLOSED

    Keep out of reach of children.

    Distributed by:

    Bausch + Lomb, a division of Bausch Health US, LLC

    Bridgewater, NJ 08807 USA

    Manufactured by:

    Bausch & Lomb Incorporated

    Tampa, FL 33637 USA

    © 2020 Bausch & Lomb Incorporated or its affiliates

    Revised: February 2020

    9130703 (Folded)

    9130603 (Flat)

  • PRINCIPAL DISPLAY PANEL

    pdp

  • 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:68071-5267(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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-5267-33.5 g in 1 BOX; Type 0: Not a Combination Product06/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06404604/25/2008
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-5267)
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