Label: CLINERE EAR WAX REMOVER- carbamide peroxide liquid

  • NDC Code(s): 68229-102-01, 68229-102-02, 68229-102-03
  • Packager: Quest Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2024

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  • Active Ingredient

    Carbamide Peroxide 6.5%

  • Purpose

    Earwax Removal Aid

  • Uses

    For occassional use as an aid to soften, loosen and remove excess 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 eardrum
    • 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 four 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 right away.

  • Directions

    FOR USE IN THE EAR ONLY.

    Adults and children over 12 years of age:

    • tilt head sideways and place 5-10 drops into each ear canal.
    • Tip of applicator should not enter ear canal.
    • Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear.
    • Use twice daily for up to four days if needed, or as directed by a doctor.
    • Any wax remaining in the ear may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe, or by use of the included Clinere® ear cleaning tool. (See separate directions)

    Children under 12 years: Consult a doctor.

  • Other Information

    • Store at 15° - 30°C (59° - 86°F)
    • Avoid exposing bottle to excessive heat or direct sunlight
    • Store bottle in the outer carton
    • Keep cap on bottle when not in use
    • Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling sound.
  • Inactive Ingredients

    Anhydrous Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Water

  • Questions?

    1-800-328-5890

    Weekdays 8:30am -5:00pm CST

  • Clinere® Earwax Removal Kit w/4 Clinere® Ear Cleaners and 1 x 0.5 Fl Oz Carbamide Peroxide Bottle

    PDP

  • INGREDIENTS AND APPEARANCE
    CLINERE EAR WAX REMOVER 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-102
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.065 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68229-102-032 in 1 CARTON03/04/2022
    1NDC:68229-102-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68229-102-021 in 1 CARTON03/04/2022
    2NDC:68229-102-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01403/04/2022
    Labeler - Quest Products (075402441)
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