EARWAX REM

Manufacturer
CVS | Product Quest Mfg
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#

ProductEARWAX REM CVS
Active ingredientCarbamide Peroxide
Label structure7 sections

Indications and uses

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                                                   Purpose
Carbamide Peroxide 6.5%......................................................Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings
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 ear wax remains after use of this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
FOR USE IN THE EAR ONLY
adults and children over 12 years of age:
• tilt head sideways • place 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 the ear with warm water, using a soft rubber bulb ear syringe children under 12 years: consult a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-041-072020-01-31C16284748780-19d75b9d1-1da0-f424-e053-dadaa90a57ce5a910721-4b33-42f0-b35c-7eea8f7d1898

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-040-01EARWAX REMCVS15 mL in 1 BOTTLESOLUTION/ DROPS15 mL6.5 g in 100mL2
69842-041-07EARWAX REMCVS1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-040EARWAX REM CVS (CARBAMIDE PEROXIDE 6.50%) KIT [CVS]2Unmatched20171120_5a910721-4b33-42f0-b35c-7eea8f7d1898.zip
69842-041EARWAX REM CVS (CARBAMIDE PEROXIDE 6.50%) KIT [CVS]2Legacy NDC, 2 package rows20171120_5a910721-4b33-42f0-b35c-7eea8f7d1898.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-04069842-040-01
69842-04169842-041-07

Ingredients#

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

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

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
0dc97168-281b-4187-a54a-67eab90d5e3b5a910721-4b33-42f0-b35c-7eea8f7d18982017-11-20WarningsExact identifier
spl id: 0dc97168-281b-4187-a54a-67eab90d5e3b
spl set id: 5a910721-4b33-42f0-b35c-7eea8f7d1898

Reported adverse events (FAERS/openFDA)#

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