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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 18, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

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

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
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  • 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.

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  • 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
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  • 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
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  • Inactive ingredient

    white petrolatum

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    Distributed by McKesson
    One Post Street, San Francisco, CA 94104

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  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    NDC 62011-0097-1

    Compare to Polysporin®
    Active Ingredients*

    Health Mart®

    FIRST AID

    Double Antibiotic Ointment

    bacitracin zinc • polymyxin B sulfate

    NET WT 1 oz (28.4 g)
    Antibiotic Ointment

    PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    DOUBLE ANTIBIOTIC 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0097
    Route of Administration TOPICAL
    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)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62011-0097-1 1 in 1 CARTON 03/21/2012
    1 28.4 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
    OTC MONOGRAPH FINAL part333B 03/21/2012
    Labeler - Health Mart (177667227)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(62011-0097)
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