Label: TRIPLE ANTIBIOTIC- bacitracin, neomycin sulfate and polymyxin b sulfate ointment 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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  • Active ingredient (in each gram)

    Bacitracin 400 units

    Neomycin sulfate equivalent to 3.5 mg of neomycin base

    Polymyxin B 5,000 units as polymyxin B sulfate

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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

    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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • Directions

    clean the affected area
    apply a small amount of this product (an amount equal to the surface area of 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

    Compare to the active ingredients in Neosporin®

    first aid

    triple antibiotic ointment

    bacitracin - neomycin sulfate - polymyxin B sulfate

    first aid antibiotic ointment

    helps prevent infection in minor cuts, scrapes and burns

    Triple Antibiotic Ointment Carton Image 1
    Triple Antibiotic Ointment Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin, neomycin, polymyxin b ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0067
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN (BACITRACIN) BACITRACIN 400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg  in 1 g
    POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM  
    LIGHT MINERAL OIL  
    Product Characteristics
    Color WHITE (Translucent) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0067-2 1 in 1 CARTON
    1 56 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 08/01/2005
    Labeler - Rite Aid Corporation (014578892)
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