Label: LEADER TRIPLE ANTIBIOTIC - bacitracin, neomycin 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 03/12

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

  • ACTIVE INGREDIENT

    Active Ingredients (each gram contains)                                                                   Purpose

    Bacitracin 400 units ...............................................................................................First Aid Antibiotic

    Neomycin Sulfate equivalent to 3.5mg of Neomycin Base ........................................First Aid Antibiotic

    Polymyxin-B Sulfate 5000 units ..............................................................................First Aid Antibiotic

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  • PURPOSE

    Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
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  • WARNINGS

    Warnings

    For external use only

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  • DO NOT USE

    Do not use

    • in the eyes
    • if you are allergic to any of the ingredients
    • over large areas of the body
    • longer than 1 week unless directed by a doctor
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  • ASK DOCTOR

    Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

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  • STOP USE

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction 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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  • INDICATIONS & USAGE

    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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  • STORAGE AND HANDLING

    Other information

    • store at 15o to 25oC (59o to 77oF)
    • Lot No. and Exp. Date: see box or see crimp of tube
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  • INACTIVE INGREDIENT

    Inactive ingredients

    liquid paraffin, white petrolatum, polyoxyl 40 stearate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water

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  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    CIN 1068808

    www.myleader.com

    1-800-200-6313

    Made in Korea

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  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

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  • INGREDIENTS AND APPEARANCE
    LEADER TRIPLE ANTIBIOTIC  
    bacitracin, neomycin sulfate, polymyxin-b sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-273
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN (BACITRACIN) BACITRACIN 400 [iU]  in 1 g
    NEOMYCIN (NEOMYCIN) NEOMYCIN 3.5 mg  in 1 g
    POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    MINERAL OIL  
    PETROLATUM  
    POLYOXYL 40 STEARATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-273-10 1 in 1 CARTON
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/01/2012
    Labeler - CARDINAL HEALTH (097537435)
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