Label: DOUBLEANTIBIOTICOINTMENT- bacitracin zinc, polymyxin b sulfate ointment

  • NDC Code(s): 69396-029-30
  • Packager: Trifecta Pharmaceuticals USA LLC
  • 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 November 20, 2017

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

  • Active Ingredient

    Bacitracin 500 Units

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  • Purpose

    First Aid Antibiotic

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  • Active Ingredient

    Polymyxin B

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  • Purpose

    First Aid Double Antibiotic Ointment

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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

    • 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 puncture wounds
    • animal bites
    • serious burns
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  • Stop use and ask doctor if:

    • You need to use longer than 1 week
    • Condition persists or gets worse
    • rash or other allergic reaction develops
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  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center immediately.

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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

    Store between 20° to 25°C (68° to 77°F)

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  • Inactive Ingredients

    White Petrolatum

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  • Questions?

    Call 1-888-296-9067

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  • Distributed By:

    Trifecta Pharmaceuticals USA™

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL, 33301, USA

    1-888-296-9067

    www.trifecta-pharma.com

    Product of PRC

    This product is not manufactured or distributed by Johnson & Johnson Consumer Products company, owner of the registered trademark Polysporin®

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  • INGREDIENTS AND APPEARANCE
    DOUBLEANTIBIOTICOINTMENT 
    bacitracin zinc, polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-029
    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 10000 [USP'U]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69396-029-30 1 in 1 BOX 05/04/2017
    1 28 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 05/04/2017
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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