Label: WALGREENS  BACITRACIN ZINC- bacitracin zinc ointment 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (each gram contains)

    Bacitracin Zinc 500 units

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  • Purpose

    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 unless directed by a doctor

    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 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 at room temperature
    • see carton or tube crimp for lot number and expiration date
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  • Inactive ingredients

    mineral oil, white petrolatum

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

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  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    Bacitracin Zinc
    Ointment USP

    First Aid Antibiotic Ointment

    Well at
    Walgreens

    WALGREENS PHARMACIST RECOMMENDED‡

    NET WT 1 OZ (28.4 g)

    Principal Display Panel - 28.4 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    WALGREENS   BACITRACIN ZINC
    bacitracin zinc ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-2075
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bacitracin Zinc (Bacitracin) Bacitracin 500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    mineral oil  
    petrolatum  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-2075-02 1 in 1 CARTON
    1 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 05/11/2006
    Labeler - Walgreen Company (008965063)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(0363-2075)
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