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

  • Category: HUMAN OTC DRUG LABEL

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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (each gram contains) 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

    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.

  • 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
  • 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.
  • Inactive ingredient

    white petrolatum

  • Questions?

    Call 1-877-745-6888

  • SPL UNCLASSIFIED SECTION

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

  • 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
  • INGREDIENTS AND APPEARANCE
    POLY BACITRACIN 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52426-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin zinc - UNII:89Y4M234ES) Bacitracin zinc500 [iU]  in 1 g
    Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B sulfate10000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52426-420-051 in 1 CARTON
    114.2 g in 1 TUBE
    2NDC:52426-420-061 in 1 CARTON
    228.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B09/23/2010
    Labeler - Phoenix Global Supply Group, Inc (843189908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Axellia Pharmaceuticals AS561816174MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Axellia Pharmaceuticals ApS305814345MANUFACTURE
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