Label: DG POLY ANTIBIOTIC FIRST AID ANTIBIOTIC- bacitracin and polymyxin b sulfate 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 2, 2019

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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 the risk of infection in minor cuts, scrapes, and 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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

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  • Directions

    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of a finger tip) on the area up to 3 times daily
    • may be covered with a sterile bandage
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  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING
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  • Inactive ingredient

    petrolatum

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  • Questions or comments?

    1-888-309-9030

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY DOLGENCORP, LLC
    100 MISSION RIDGE
    GOODLETTSVILLE, TN 37072

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  • PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

    DG™ | health

    NDC 55910-342-24

    Compare to the active
    ingredients of Polysporin®
    First Aid Antibiotic Ointment*

    Poly Antibiotic Ointment
    First Aid Antibiotic Ointment

    Bacitracin Zinc • Polymyxin B Sulfate

    First Aid to Help Prevent Infection in Minor Cuts, Scrapes & Burns

    NET WT 0.5 OZ (14 g)

    Principal Display Panel - 14 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    DG POLY ANTIBIOTIC   FIRST AID ANTIBIOTIC
    bacitracin and polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-342
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bacitracin (UNII: 58H6RWO52I) (Bacitracin - UNII:58H6RWO52I) Bacitracin 500 U  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B 10000 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:55910-342-24 1 in 1 CARTON 10/19/2017
    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 06/14/2010
    Labeler - Dollar General (068331990)
    Establishment
    Name Address ID/FEI Business Operations
    Natureplex LLC 062808196 MANUFACTURE(55910-342)
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