Label: DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment

  • NDC Code(s): 51672-2044-2
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Bacitracin zinc 500 unitsFirst aid antibiotic
    Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
  • Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week

    Ask a doctor before use

    • on deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • condition persists or gets worse
    • a rash or other allergic reaction develops

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the affected area and dry thoroughly
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • Other information

    • To open: unscrew cap, pull tab to remove foil seal.
    • store between 20° and 25°C (68° and 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredient

    white petrolatum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    NDC 51672-2044-2

    Compare to the
    active ingredients in
    Polysporin ®*

    Original Strength

    Double Antibiotic
    Ointment

    Bacitracin Zinc • Polymyxin B Sulfate

    First Aid Antibiotic Ointment

    NET WT 1 oz (28.4 g)

    PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    DOUBLE ANTIBIOTIC 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2044
    Route of AdministrationTOPICAL
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2044-21 in 1 CARTON09/06/2018
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00412/05/1990
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(51672-2044)
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