Label: DG HEALTH POLY ANTIBIOTIC- bacitracin, and polymyxin b ointment

  • 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 August 11, 2016

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  • ACTIVE INGREDIENT

    Active ingredients (in each gram)                         Purpose

    Bacitracin 500 units.............................................. First aid antibioitic

    Polymyxin B 10,000 units...................................... First aid antibiotic

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  • PURPOSE

    Uses first aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
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  • WARNINGS

    Warnings

    For external use only.

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  • DO NOT USE

    Do not use

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

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
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  • STOP USE

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persits or gets worse
    • rash or other allergic reaction develops
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • INDICATIONS & USAGE

    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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  • STORAGE AND HANDLING

    Other information

    • store at 20° to 25°C (68° to 77°F)
    • lot no. & exp. date: see box or see crimp of tube
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  • INACTIVE INGREDIENT

    Inactive ingredient: white petrolatum base

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  • DOSAGE & ADMINISTRATION

    Distributed by:

    Dolgencorp, LLC

    100 Mission Ridge

    Goodlettsville, TN 37072

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    DG HEALTH POLY ANTIBIOTIC 
    bacitracin, and polymyxin b ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-586
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [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:55910-586-14 1 in 1 CARTON 08/11/2016
    1 14 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 08/11/2016
    Labeler - Dolgencorp, Inc. (068331990)
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