CLINERE EAR WAX REMOVER- carbamide peroxide liquid 
Quest Products

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.

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Clinere Ear Wax Removal Kit

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:

Children under 12 years: Consult a doctor.

Other Information

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

102-02

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)

Revised: 3/2022
Document Id: d967edf6-f413-7768-e053-2a95a90a0303
Set id: d967eac3-0aac-a7ae-e053-2995a90a0e1e
Version: 1
Effective Time: 20220304
 
Quest Products