FDA.reportPublic FDA data

GoodSense Ear Wax

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:25

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

Relabeled By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Earwax Removal Kit
Earwax Removal Kit

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1281501987419_V2_lo.jpg
Data codeData Matrix**040926*987419_V2_lo.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8615-1GoodSense Ear Wax Removal Kit15 mL in 1 BOTTLELIQUID151
68788-8615-1GoodSense Ear Wax Removal Kit1 in 1 BOXLIQUID11

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
68788-861568788-8615-1
50804-117

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 CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TARTARIC ACIDW4888I119HIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.9a4198d2-cbea-466a-a252-d5c63d9ea0c12026-04-09WarningsExact identifier
ndc (package): 68788-8615-1
ndc (product): 68788-8615
ndc11 (package): 68788861501
spl id: 9a4198d2-cbea-466a-a252-d5c63d9ea0c1
spl set id: 9a4198d2-cbea-466a-a252-d5c63d9ea0c1
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEGeiss, Destin & Dunn, Inc31ea324f-a9a1-7865-e063-6294a90a92e82025-09-19WarningsExact identifier
ndc (product): 50804-117

Reported adverse events (FAERS/openFDA)#

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