FDA.reportPublic FDA data

GoodSense Ear Wax Removal Kit

Manufacturer
Geiss, Destin & Dunn, Inc | Derma Care Research Labs, LLC | Derma Care Research Labs
Effective date
2025-09-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:14:14

Label at a glance#

ProductGoodSense Ear Wax Removal Kit
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5%

OTC - PURPOSE SECTION

Earwax removal aid

INDICATIONS & USAGE SECTION

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

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) in the ear drum or after ear surgery, unless directed by a doctor
  • for more than 4 days; if excessive earwax remains after use of this product, consult a doctor

When using this product avoid contact with yes. If accidental contact with yes occurs, flush eyes with water and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

FOR USE IN 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, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncartonCartonCarton

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-117-01GoodSense Ear Wax Removal Kit15 mL in 1 BOTTLELIQUID152
50804-117-01GoodSense Ear Wax Removal Kit1 in 1 BOXLIQUID12
50804-117-11GoodSense Ear Wax Removal Kit1 in 1 BOXLIQUID12
50804-117-11GoodSense Ear Wax Removal Kit15 mL in 1 BOTTLELIQUID152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-117-01ML - Milliliter50804-1173c49e2f7-e3fa-4e91-8bf9-8ec43040d16712025-07-08
50804-117-11ML - Milliliter50804-117fa69c67c-3f91-4adb-8dbe-07d654205c9812026-02-05

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
50804-11750804-117-01, 50804-117-11

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
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TARTARIC ACIDW4888I119HIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
CITRIC ACID2968PHW8QPIACT

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
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEGeiss, Destin & Dunn, Inc31ea324f-a9a1-7865-e063-6294a90a92e82025-09-19WarningsExact identifier
ndc (package): 50804-117-01
ndc (package): 50804-117-11
ndc (product): 50804-117
ndc11 (package): 50804011701
ndc11 (package): 50804011711
spl id: 3f2f88ef-2715-ebff-e063-6394a90ae84a
spl set id: 31ea324f-a9a1-7865-e063-6294a90a92e8

Reported adverse events (FAERS/openFDA)#

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