Label: EARWAX REMOVAL KIT liquid

  • 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 November 23, 2013

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  • Active ingredient(s)

     Carbamide Peroxide 6.5%

  • Purpose

    Earwax Removal Aid

  • Use(s)

     For occasional use to soften, loosen and remove excessive earwax.

  • Warnings

    Warning

     For External Use Only

    Do not use

    •  In the eye
    • for more than 4 days

    Ask a doctor before use if you have

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

    Stop use and ask a doctor if

     Stop use and ask a doctor if excessive earwax remains after use

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

     FOR USE IN THE EAR ONLY

    Adults and children 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 my be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.  Children under 12 years of age, consult a doctor.

  • Other information

     Do not use if imprinted seal on cap is broken or missing.

  • Storage

    • Store at controlled room temperature 15 to 30C (59 to 86F)
    • KEEP IN A DRY PLACE
  • Principal Display Panel

     Principle display panel:

    Leader Ear Wax Kit Carton

    Leader Ear Wax Kit Carton

  • Inactive Ingredients

     anhydrous Glycerin

  • Questions or Comments?


    Call 1-800-328-2742

  • INGREDIENTS AND APPEARANCE
    EARWAX REMOVAL KIT 
    earwax removal kit liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-458
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE6.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 120.0 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-458-0315 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34402/06/2012
    Labeler - Cardinal Health (097537435)
    Registrant - Continental Manufacturing Chemist, Inc. (005278007)
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