Label: POLYSPORIN- polymyxin b sulfate and bacitracin zinc powder

  • NDC Code(s): 58232-4033-1
  • Packager: Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, 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 June 16, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

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

    first aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
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  • Warnings

    For external use only.

    Do not use

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

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • 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 light dusting of the powder on the area 1 to 3 times daily
    • may be covered with a sterile bandage
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  • Other information

    • store at 20° to 25°C (68° to 77° F)
    • do not refrigerate
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  • Inactive ingredient

    lactose base

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  • Questions?

    call 1-800-223-0182

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  • PRINCIPAL DISPLAY PANEL - 10g Bottle Label

    #1
    DERMATOLOGIST
    RECOMMENDED

    Polysporin®

    BACITRACIN ZINC • POLYMYXIN B SULFATE
    First Aid Antibiotic Powder

    Helps prevent infection in minor cuts, scrapes, and burns

    NET WT 0.35 oz (10g)

    Principal Display Panel - 10g Bottle Label
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  • INGREDIENTS AND APPEARANCE
    POLYSPORIN 
    polymyxin b sulfate and bacitracin zinc powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58232-4033
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B Sulfate 10000 [USP'U]  in 1 g
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin Zinc 500 [USP'U]  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58232-4033-1 1 in 1 CARTON
    1 10 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333 06/14/2010
    Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)
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