FDA.reportPublic FDA data

EarWax Removal Drops Drug Facts

Manufacturer
CVS | Product Quest Mfg, LLC
Effective date
2017-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:01

Label at a glance#

ProductCVS EARWAX REM CVS
Active ingredientCarbamide Peroxide
Label structure11 sections

Indications and uses

for occasional use as an aid to soften, loosen and remove excessive ear wax

Dosage and administration

​FOR USE IN THE EAR ONLY adults and children over 12 years of age: ​tilt head sideways palce 5 to 10 drops into ear tip of applicator should not enter ear canal keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear use twice daily for up to four days if needed, or as directed by a doctor any wax remaining after treatment may be removed by gently flushing ear with warm water, usi...

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 occasional use as an aid to soften, loosen and remove excessive ear wax

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 the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you need to use for more than four days
  • excessive ear wax remains after use of this product

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Posion 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
  • palce 5 to 10 drops into ear
  • tip of applicator should not enter ear canal
  • keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
  • use twice daily for up to four days if needed, or as directed by a doctor
  • any wax remaining after treatment may be removed by gently flushing ear with warm water, using a soft rubber bulb ear syringe

​children under 12 years: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store bottle in the outer carton
  • product foams on contact with ear wax due to release of oxygen. There may be an associated "cracklling" sound.
  • keep cap on bottle when not in use 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Glycerin
Mineral Oil
Oxyquinoline Sulfate
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN2
702050carbamide peroxide 65 MG/ML Otic SolutionSCD2
702050carbamide peroxide 6.5 % Otic SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-042-072020-01-31C16284748780-19d75b9d1-1d9d-f424-e053-dadaa90a57ceEarWax Removal Drops Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-042-07CVS EARWAX REMCVS1 in 1 KITKIT12
69842-043-01CVS EARWAX REMCVS15 mL in 1 BOTTLESOLUTION/ DROPS15 mL6.5 g in 100mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-042CVS EARWAX REM CVS (CARBAMIDE PEROXIDE 6.50%) KIT [CVS]2Legacy NDC, 2 package rows20171120_bd844af4-fbf0-459b-823d-b2a675f90c19.zip
69842-043CVS EARWAX REM CVS (CARBAMIDE PEROXIDE 6.50%) KIT [CVS]2Unmatched20171120_bd844af4-fbf0-459b-823d-b2a675f90c19.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-04269842-042-07
69842-04369842-043-01

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
Carbamide Peroxide31PZ2VAU81ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CHAMOMILEFGL3685T2XIACT
GLYCERINPDC6A3C0OXIACT
OXYQUINOLINE SULFATE61VUG75Y3PIACT
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT

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
07b0bb01-eb45-4646-a599-0df2b73aabd7bd844af4-fbf0-459b-823d-b2a675f90c192017-11-20WarningsExact identifier
spl id: 07b0bb01-eb45-4646-a599-0df2b73aabd7
spl set id: bd844af4-fbf0-459b-823d-b2a675f90c19

Reported adverse events (FAERS/openFDA)#

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