Label: POLY BACITRACIN- bacitracin zinc and polymyxin b sulfate ointment

  • NDC Code(s): 52426-420-05, 52426-420-06
  • Packager: Phoenix Global Supply Group, Inc
  • 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 September 28, 2010

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (each gram contains) 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

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition persists or gets worse
    • you need to use longer than 1 week
    • rash or other allergic reaction develops

    Keep out of 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
    • 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 at 20°-25°C (68°-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 1-877-745-6888

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Phoenix Global Supply Group, Inc.
    White Plains, NY 10604

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  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    Poly Bacitracin
    Bacitracin Zinc • Polymyxin B Sulfate

    First Aid Antibiotic Ointment

    NDC 52426-420-06

    NET WT 1 oz (28.4 g)

    Principal Display Panel - 28.4 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    POLY BACITRACIN 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52426-420
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin zinc - UNII:89Y4M234ES) Bacitracin zinc 500 [iU]  in 1 g
    Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B sulfate 10000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52426-420-05 1 in 1 CARTON
    1 14.2 g in 1 TUBE
    2 NDC:52426-420-06 1 in 1 CARTON
    2 28.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333B 09/23/2010
    Labeler - Phoenix Global Supply Group, Inc (843189908)
    Establishment
    Name Address ID/FEI Business Operations
    Axellia Pharmaceuticals AS 561816174 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Axellia Pharmaceuticals ApS 305814345 MANUFACTURE
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