EarWax Removal Drops Drug Facts

Manufacturer
Amerisource Bergen | Product Quest Mfg, LLC
Effective date
2016-05-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:45:53

Label at a glance#

ProductEar System GNP
Active ingredientCarbamide Peroxide
Label structure7 sections

Indications and uses

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

Dosage and administration

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 the ear • use twice daily for up to 4 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 r...

Label contents#

Full prescribing information#

Active ingredient                     Purpose

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5%        Softens & removes wax

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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 eardrum or after ear surgery, unless directed by a doctor.
When using this product avoid contact with eyes

Stop use and ask a doctor if excessive earwax remains after use of this product for four consecutive days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
In case of accidental ingestion, seek professional or contact a Poison Control Center immediately.

DirectionsDirections For use in the ear only.

DOSAGE & ADMINISTRATION SECTION

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 the ear
• use twice daily for up to 4 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glyceryn, Oxyquinoline

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage 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
24385-501-072020-01-31C16284748780-19d75b9d0-7858-f424-e053-dadaa90a57ceEarWax Removal Drops Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24385-500-01Ear SystemGNP15 mL in 1 BOTTLESOLUTION/ DROPS15 mL6.5 g in 100mL2
24385-501-07Ear SystemGNP1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-500EAR SYSTEM GNP (CARBAMIDE PEROXIDE 6.50%) KIT [AMERISOURCE BERGEN]2Unmatched20160505_b326b175-e792-44ed-a68c-9aa587bb717c.zip
24385-501EAR SYSTEM GNP (CARBAMIDE PEROXIDE 6.50%) KIT [AMERISOURCE BERGEN]2Legacy NDC, 2 package rows20160505_b326b175-e792-44ed-a68c-9aa587bb717c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24385-50024385-500-01
24385-50124385-501-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
664ed3d6-89c2-4336-a34f-d9553ab35cc9b326b175-e792-44ed-a68c-9aa587bb717c2016-05-04WarningsExact identifier
spl id: 664ed3d6-89c2-4336-a34f-d9553ab35cc9
spl set id: b326b175-e792-44ed-a68c-9aa587bb717c

Reported adverse events (FAERS/openFDA)#

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