FDA.reportPublic FDA data

Quality Choice Earwax Removal Kit, Earwax Removal Aid & Bulb

Manufacturer
Chain Drug Marketing Association, Inc. | Bell Pharmaceuticals, Inc.
Effective date
2026-06-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-16 05:10:17

Label at a glance#

ProductQuality Choice Earwax Removal Kit Earwax Removal Aid and Bulb
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

FOR 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 w...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For use in the ear only

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

• ear drainage or discharge • ear pain • irritation or rash in the ear • dizziness • an injury or perforation (hole) of the ear drum • recently had ear surgery

When using this product

OTC - WHEN USING SECTION

• avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you need to use for more than 4 days • excessive earwax remains after use of this product.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

FOR 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 or ear syringe

Children under 12 years:Consult a doctor

Other information

SPL UNCLASSIFIED SECTION

• Avoid exposing bottle to excessive heat and direct sunlight
• Store bottle in the outer carton
• Store at 15°–30°C (59°–86°F)
• Keep cap on bottle when not in use
• Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound
• Do not use if tamper-evident safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions?

OTC - QUESTIONS SECTION

1-800-328-5890

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
83324-28283324-282-05
83324-28383324-283-05

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.c68b40d9-c1d4-4425-8063-50c00299e7182026-06-10WarningsExact identifier
ndc (package): 83324-283-05
ndc (product): 83324-283
ndc11 (package): 83324028305
Quality Choice Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.b2a641da-e070-4223-b836-5ca9ffb89f3f2026-06-10WarningsExact identifier
ndc (package): 83324-283-05
ndc (package): 83324-282-05
ndc (product): 83324-282
ndc11 (package): 83324028305
ndc11 (package): 83324028205
spl id: 53e862d0-39a8-6e5f-e063-6294a90a238a
spl set id: b2a641da-e070-4223-b836-5ca9ffb89f3f

Reported adverse events (FAERS/openFDA)#

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