Clinere Ear Wax Removal Kit

Clinere Ear Wax Remover by

Drug Labeling and Warnings

Clinere Ear Wax Remover by is a Otc medication manufactured, distributed, or labeled by Quest Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 external use only

Do not use

This product for more than 4 days

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 eyes. If accidental contact occurs, flush eyes with warm water.

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 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 of age: Consult a doctor.

Other Information

• Store at 15° - 30°C (59° - 86°F)
• Avoid excessive heat.
• Keep cap on bottle when not in use

Inactive Ingredients

Citric Acid, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Trisodium Citrate Dihydrate, Water

Clinere® Earwax Removal Kit w/12 Clinere® Ear Cleaners and 2x 0.5 Fl Oz Carbamide Peroxide Bottles

CLINERE EAR WAX REMOVER 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68229-101
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	0.065 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68229-101-04	2 in 1 CARTON	12/09/2021	02/25/2022
1	NDC: 68229-101-01	15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68229-101-03	1 in 1 CARTON	01/07/2022	02/25/2022
2	NDC: 68229-101-01	15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	12/09/2021	02/25/2022

Labeler - Quest Products (075402441)

Revised: 2/2022

Document Id: d8dba5d5-573d-a9cb-e053-2a95a90a83e3

34390-5

Set id: d2baba3e-4dd8-756c-e053-2a95a90a54dc

Version: 3

Effective Time: 20220225