Label: LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF- bacitracin,neomycin,polymxin, pramoxine ointment

  • NDC Code(s): 70000-0625-1
  • Packager: Cardinal Health 110 dba LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 13, 2025

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

  • DRUG FACTS

  • Active Ingredient

    Bacitracin zinc 500 Units

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Neomycin Sulfate 3.5mg

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Polymyxin B Sulfate 10,000 Units

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Pramoxine HCL 10mg

  • Purpose

    External Analgesic

  • Uses

    First Aid to help prevent infection and for temporary relief of pain or discomfort in minor

    • Cuts
    • Scrapes
    • Burns
  • Warnings

    For external use only. Do not use:

    • In eyes
    • Over large areas of the body
    • If you are allergic to any of the ingredients

  • Ask a Doctor before Use

    Ask Doctor before use if you have:

    • Deep or puncture wouns
    • Animal bites
    • Serious burns
  • Stop Use and ask a Doctor if:

    • Symptoms persists for more than 1 week or clear up and occur again within a few days.
    • Condition persists or gets worse
    • You need to use longer than 1 week
    • A rash or other allergic reaction develops
  • Keep out of Reach of Children

    If Swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    Adults and children 2 years of age and older.

    • Clean the affected area and dry thoroughly
    • 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
    • Children under 2 years of age: ask doctor
  • Other Information

    • Store at 20° to 25°C (68° to 77°F)
    • See carton or tube crimp for lot number and expiration date
  • Inactive Ingredient:

    mineral oil, Petrolatum

  • Questions?

    Call 1-888-296-9067

  • Distributed By:

    Distributed By:
    Cardinal Health

    Dublin, Ohio 43017

    www.myleader.com

    1-800-200-6313

    Essential to care since 1979

    This product is not manufactured or distributed by Johnson & Johnson a registered trademark of Neosporin Plus Pain Relief

    ©Cardinal Health. All rights reserved, CARDINAL HEALTH the Cardinal health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

  • Packaging

    5809660 LEADER TRIPLE ANTIBIOTIC PAIN RELIEF 1OZ 041025 CDER

  • INGREDIENTS AND APPEARANCE
    LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF 
    bacitracin,neomycin,polymxin, pramoxine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0625
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0625-11 in 1 BOX02/15/2023
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00402/15/2023
    Labeler - Cardinal Health 110 dba LEADER (063997360)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)