FDA.reportPublic FDA data

Earwax Removal Drops

Manufacturer
Humco Holding Group, Inc | Pharma Nobis, LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:04:40

Label at a glance#

ProductEarwax Removal Drops
Active ingredientCARBAMIDE PEROXIDE
Label structure11 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Citric Acid

Flavor

Glycerin

Propylene Glycol

Sodium Lauroyl Sarcosinate

Sodium Stannate

Purified Water

OTC - PURPOSE SECTION

Earwax removal aid.

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

WARNINGS SECTION

For External Use Only.

Ask a doctor before use if you have:

Ear drainage or discharge

Ear pain, irritation, or rash in the ear

Recently had ear surgery

Dizziness

An injury or perforation (hole) of the eadrum

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5%

INDICATIONS & USAGE SECTION

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

CVS Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSWax.jpgCVSWax.jpgcartoncarton

Leader Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader2022Leader2022LDREarwax45.jpgLDREarwax45.jpgLDREwawax90.jpgLDREwawax90.jpg

Rite Aid Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rite Aid Earwax Kit 2022Rite Aid Earwax Kit 2022RAEarwax45.jpgRAEarwax45.jpgRAEarwax90.jpgRAEarwax90.jpg

Major Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MajorEarwax90.jpgMajorEarwax90.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9133-45Earwax Removal Drops1 in 1 CARTONLIQUID15
0395-9133-45Earwax Removal Drops15 mL in 1 BOTTLE, DROPPERLIQUID155
0395-9133-90Earwax Removal Drops15 mL in 1 CONTAINERLIQUID155
0395-9133-90Earwax Removal Drops1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9133EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [HUMCO HOLDING GROUP, INC]5Current NDC, Legacy NDC, 4 package rows20231216_a8c052d8-fb9c-09f2-e053-2a95a90a37af.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
0395-91330395-9133-90, 0395-9133-45

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
WATER059QF0KO0RIACT
SODIUM STANNATENJ7C1V83KGIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

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
Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Humco Holding Group, Inca8c052d8-fb9c-09f2-e053-2a95a90a37af2023-12-15WarningsExact identifier
ndc (package): 0395-9133-90
ndc (package): 0395-9133-45
ndc (product): 0395-9133
ndc11 (package): 00395913390
ndc11 (package): 00395913345
spl id: 0c93a2f8-8199-15fb-e063-6394a90a5521
spl set id: a8c052d8-fb9c-09f2-e053-2a95a90a37af

Reported adverse events (FAERS/openFDA)#

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