Label: SUNMARK  DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate 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 02/13

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  • 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 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 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

    sunmark

    double antibiotic ointment
    Bacitracin Zinc-Polymyxin B Sulfate

    FIRST AID ANTIBIOTIC

    NET WT 1 OZ (28.4 g)

    Principal Display Panel - 28.4 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    SUNMARK   DOUBLE ANTIBIOTIC
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-274
    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
    Polymyxin B sulfate (Polymyxin B) Polymyxin B 10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    petrolatum  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-274-72 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 03/21/2012
    Labeler - McKesson (177667227)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49348-274)
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