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

  • Category: HUMAN OTC DRUG LABEL

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 January 22, 2018

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  • 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

  • PURPOSE

    Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only

  • 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
  • ASK DOCTOR

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

  • STOP USE

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
  • 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

  • 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
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    CIN 1068808

    www.myleader.com

    1-800-200-6313

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    6880.1

  • INGREDIENTS AND APPEARANCE
    LEADER TRIPLE ANTIBIOTIC 
    bacitracin, neomycin sulfate, polymyxin-b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-273
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-273-101 in 1 CARTON01/01/2015
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/01/2012
    Labeler - CARDINAL HEALTH (097537435)
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