Label: LEADER TRIPLE ANTIBIOTIC PLUS- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride 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 December 11, 2017

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients (in each gram)                                                                      Purpose

    Bacitracin Zinc 500 units .................................................................................First aid antibiotic

    Neomycin Sulfate 3.5 mg.................................................................................First aid antibiotic

    Polymyxin-B Sulfate 10,000 units.....................................................................First aid antibiotic

    Pramoxine hydrochloride 10 mg........................................................................Pain reliever

  • PURPOSE

    Uses

    help prevent infection and temporarily relieves pain due to

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only

    Allergy alert: do not use if allergic to any of the ingredients

  • DO NOT USE

    Do not use

    • in or near the eyes
    • over large areas of the body
    • longer than 1 week
  • ASK DOCTOR

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

  • WHEN USING

    When using this product do not use longer than 1 week

  • STOP USE

    Stop use and ask a doctor if

    • condition persists or gets worse
    • symptoms last for more than 7 days or clear up and comes back within a few days
    • a rash or other allergic reaction occurs
  • 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  

    Adults and children 2 years and older:

    • clean affected area
    • apply a small amount (equal to the surface area of the tip of a finger) on area 1 to 3 times daily
    • may be covered with a sterile bandage   
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    white petrolatum, water

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    CIN 2372167

    www.myleader.com

    1-800-200-6313

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LEADER TRIPLE ANTIBIOTIC PLUS 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-266
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  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 B10000 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-266-101 in 1 CARTON03/01/2012
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!