Label: LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB- carbamide peroxide kit

  • NDC Code(s): 70000-0688-1, 70000-0689-1
  • Packager: Cardinal Health 110 DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 10, 2024

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  • Drug Facts

  • Active ingredient

    Carbamide peroxide 6.5%.

    Purpose

    Earwax removal aid

  • Uses

    for occasional use as an aid to soften, loosen, and remove excessive earwax

  • Warnings

    For use in the ear only

    Ask a doctor before use if you have

    • ear drainage or discharge
    • ear pain
    • irritation, or rash in the ear
    • dizziness
    • an injury or perforation (hole) of the ear drum recently had ear surgery

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    • you need to use for more than 4 days
    • excessive earwax remains after use of this product

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    FOR USE IN THE EAR ONLY

    Adults and children over 12 years of age:

    • Tilt head sideways and place 5 to 10 drops into ear 
    • Tip of applicator should not enter ear canal
    • Keep drops in ear for several minutes by
    • keeping head tilted or placing cotton in the ear
    • Use twice daily for up to 4 days if needed, or as directed by a doctor
    • Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe

     Children under 12 years:consult a doctor

  • Other information

    • Avoid exposing bottle to excessive heat and direct sunlight
    • Store bottle in the outer carton
    • Store at 15-30ºC (59-86ºF)
    • Keep cap on bottle when not in use 
    • Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound.
    • Do not use if tamper-evident safety seal is broken or missing
  • Inactive ingredients

    anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

  • Questions?

    1-800-328-5890
    Weekdays 8:30-5:00 CST

  • package Labelling:

    Label.jpgLabel2.jpg

  • INGREDIENTS AND APPEARANCE
    LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB 
    carbamide peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0689
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0689-11 in 1 BOX07/09/2024
    11 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 15 mL
    Part 1 of 1
    LEADER EARWAX REMOVAL DROPS EARWAX REMOVAL AID 
    carbamide peroxide solution/ drops
    Product Information
    Item Code (Source)NDC:70000-0688
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0688-11 in 1 BOX
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01407/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01407/09/2024
    Labeler - Cardinal Health 110 DBA Leader (063997360)
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