Ear Wax Removal Drops

Manufacturer
Product Quest Mfg
Effective date
2018-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:37

Label at a glance#

ProductEar Wax Removal Drops
Active ingredientCarbamide Peroxide
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings
Do not use • if you have ear drainage or discharge, ear pain,
irritation or rash in the ear, or are dizzy; consult a doctor. • if
you have an injury or perforation (hole) of the ear drum or after
ear surgery unless directed by a doctor. • for more than four
consecutive days.
When using this product • avoid contact with eyes
Stop use and ask a doctor if • excessive ear wax remains
after use of this product for four consecutive days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away. If accidental contact
with eyes occurs, flush eyes with water and consult a doctor.

DOSAGE & ADMINISTRATION SECTION

Directions FOR USE IN THE EAR ONLY. Adults and children
over 12 years of age: tilt head sideways and 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 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 of age: consult a doctor

OTHER SAFETY INFORMATION

Other information

Protect from heat and direct sunlight.
Keep cap on bottle when not in use

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 SolutionPSN1
702050carbamide peroxide 65 MG/ML Otic SolutionSCD1
702050carbamide peroxide 6.5 % Otic SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64048-5118-12020-01-31C16284748780-19d75b9cf-df46-f424-e053-dadaa90a57ceabfbf016-fda2-44a3-8bd7-be5eb9cd8b99

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64048-5118-1Ear Wax Removal Drops15 mL in 1 BOTTLELIQUID151
64048-5118-1Ear Wax Removal Drops1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64048-5118EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [PRODUCT QUEST MFG]1Legacy NDC, 2 package rows20180817_abfbf016-fda2-44a3-8bd7-be5eb9cd8b99.zip

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
64048-511864048-5118-1

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 · Source PDF

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
f2c3033a-b17f-4cd6-97c2-d5f4d204da63abfbf016-fda2-44a3-8bd7-be5eb9cd8b992018-08-16WarningsExact identifier
spl id: f2c3033a-b17f-4cd6-97c2-d5f4d204da63
spl set id: abfbf016-fda2-44a3-8bd7-be5eb9cd8b99

Reported adverse events (FAERS/openFDA)#

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