Label: BACITRACIN- bacitracin 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 June 21, 2017

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  • Active ingredient (each gram contains)

    Bacitracin 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

    Do not use

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

    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

    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
    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 20°-25°C (68°-77°F)
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  • Inactive ingredients

    light mineral oil, white petrolatum

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Bacitracin Ointment

    First aid antibiotic ointment

    Helps prevent infection in minor cuts, scrapes & burns

    Bacitracin Ointment

    BACITRACIN, USP

    NET WT 1 OZ (28 g)

    bacitracin ointment image
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  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0075
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0075-64 1 in 1 CARTON 10/24/2016
    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 10/24/2016
    Labeler - Walgreen Company (008965063)
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