Label: BACITRACIN ZINC- bacitracin zinc ointment

  • NDC Code(s): 55319-110-56
  • Packager: Family Dollar Services Inc.
  • 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 June 19, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient (in each gram)

    Bacitracin zinc, USP 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

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  • SPL UNCLASSIFIED SECTION

    Allergy Allert:   •do not use if allergic to any of the ingredients

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  • DO NOT USE

    Do not use •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 punture wounds  •animal bites  •serious burns

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  • WHEN USING

    When using this product  •do not use longer than 1 week unless directed by a doctor

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  • STOP USE

    Stop use and ask a doctor if  •condition persists or gets worse  •a rash or other allergic reation 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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  • DOSAGE & ADMINISTRATION

    Directions  •clean 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 at room temperature 59°-77°F (15°-25°C).  •Before using any medication, read all label directions.  Keep carton, it contains important information.

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  • INACTIVE INGREDIENT

    Inactive ingredient  white petrolatum

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  • QUESTIONS

    Questions? 1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

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  • PRINCIPAL DISPLAY PANEL

    Family wellness
    NDC 55319-110-56
    Bacitracin Zinc Ointment, USP
    First Aid Antibiotic
    Helps prevent infection in minor cuts, scrapes and burns 

    NET WT 1 OZ (28g)

    Bacitracin Zinc Ointment
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  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-110
    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
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55319-110-56 1 in 1 CARTON 02/23/2012
    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 02/23/2012
    Labeler - Family Dollar Services Inc. (024472631)
    Registrant - Teva Pharmaceuticals USA, Inc. (001627975)
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