Label: TRIBIOTIC- bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment 

  • Label RSS
  • NDC Code(s): 50332-0032-1, 50332-0032-2, 50332-0032-3, 50332-0032-4, view more
    50332-0032-5, 50332-0032-6
  • Packager: HART Health
  • 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 10/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients (in each gram)

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg (equivalent to 3.5mg neomycin base)

    Polymyxin B Sulfate 5,000 units

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  • PURPOSE

    Purpose:

    Topical Antibiotic

    Topical Antibiotic

    Topical Antibiotic

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  • INDICATIONS & USAGE

    Uses: First aid to help prevent infection and temporarily relieve pain in
    • minor cuts
    • scrapes
    • burns
    • abrasions
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  • WARNINGS

    Warnings: For external use only

    Serious burns require immediate medical attention


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  • ADVERSE REACTIONS

    Allergy alert: Do not use if you are allergic to any of the ingredients

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  • DO NOT USE

    do not use

    • in or near the eyes
    • over large portions of the body
    • longer than 7 days unless directed by a doctor
    • more than 1 to 3 times daily
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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

    • condition worsens or lasts for more than 7 days
    • a rash or other allergic reaction occurs

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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:

    Do not use more than directed.

    Adults and children 12 years of age and over:

    • clean the affected area
    • apply 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

    Children under 12 years of age: ask a doctor

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  • INACTIVE INGREDIENT

    Petrolatum

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  • PRINCIPAL DISPLAY PANEL

    Tribiotic5.jpg

    Tribiotic5.jpg

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  • INGREDIENTS AND APPEARANCE
    TRIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50332-0032
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC 400   in 1 g
    NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 5 mg  in 1 g
    POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 5000   in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50332-0032-6 10 in 1 BOX, UNIT-DOSE
    1 .5 g in 1 PACKET
    2 NDC:50332-0032-3 25 in 1 BOX, UNIT-DOSE
    2 .5 g in 1 PACKET
    3 NDC:50332-0032-5 144 in 1 BOX, UNIT-DOSE
    3 .5 g in 1 PACKET
    4 NDC:50332-0032-1 10 in 1 BOX, UNIT-DOSE
    4 .9 g in 1 PACKET
    5 NDC:50332-0032-2 25 in 1 BOX, UNIT-DOSE
    5 .9 g in 1 PACKET
    6 NDC:50332-0032-4 144 in 1 BOX, UNIT-DOSE
    6 .9 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 10/03/2005
    Labeler - HART Health (069560969)
    Registrant - HART Health (069560969)
    Establishment
    Name Address ID/FEI Business Operations
    WaterJel Technologies 155522589 manufacture(50332-0032)
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