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
  • 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 April 25, 2023

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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 finalpart34403/04/2022
    Labeler - Quest Products (075402441)
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