FDA.reportPublic FDA data

Clinere Ear Wax Remover

Manufacturer
Quest Products
Effective date
2022-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:18:49

Label at a glance#

ProductClinere Ear Wax Remover
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Indications and uses

For occassional use as an aid to soften, loosen and remove excess earwax.

Dosage and administration

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 wa...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Earwax Removal Aid

Uses

INDICATIONS & USAGE SECTION

For occassional use as an aid to soften, loosen and remove excess earwax.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

This product for more than 4 days

Ask a Doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

101-04PDP101-04PDP

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68229-10168229-101-01, 68229-101-04, 68229-101-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d8dba5d5-573d-a9cb-e053-2a95a90a83e3d2baba3e-4dd8-756c-e053-2a95a90a54dc2022-02-25WarningsExact identifier
spl set id: d2baba3e-4dd8-756c-e053-2a95a90a54dc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.