FDA.reportPublic FDA data

Ear Drops

Manufacturer
Good Sense | Product Quest Mfg.
Effective date
2018-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:36

Label at a glance#

ProductEar Drops
Active ingredientCarbamide Peroxide
Label structure6 sections

Label contents#

Full prescribing information#

Active ingredient                        Purpose

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide  6.5%          Earwax removal aid

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION


Do not use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

DirectionsFor 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 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 INGREDIENT SECTION

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, 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
50804-508-012020-01-31C16284748780-19d75b9d0-362b-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-508-01Ear Drops1 in 1 CARTONLIQUID11
50804-508-01Ear Drops15 mL in 1 BOTTLELIQUID151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-508EAR DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [GOOD SENSE]1Legacy NDC, 2 package rows20180814_e828c3d4-219e-4c94-b962-267bcf12e930.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
50804-50850804-508-01

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Sodium Lauroyl Sarcosinate632GS99618IACT
Sodium StannateNJ7C1V83KGIACT
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
a4dee829-eeb9-49b9-855e-c0531f115fc8e828c3d4-219e-4c94-b962-267bcf12e9302018-08-10WarningsExact identifier
spl id: a4dee829-eeb9-49b9-855e-c0531f115fc8
spl set id: e828c3d4-219e-4c94-b962-267bcf12e930

Reported adverse events (FAERS/openFDA)#

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