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 January 10, 2024

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  • 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

    • 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

    • To Open: Unscrew cap, tear foil safety seal off.
    • Store at 20° to 25°C (68° to 77°F)
    • See carton or tube crimp for lot number and expiration date
  • Inactive Ingredient:

    Light 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

  • Packaging

    Leader Triple Antibiotic + Pain Relief 1oz 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)
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