FDA.reportPublic FDA data

Wax Away Earwax Removal System

Manufacturer
McKeon Products Inc | Bell Pharmaceuticals, Inc.
Effective date
2026-02-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:37:35

Label at a glance#

ProductWax Away Earwax Removal System
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 Mack’s® AquaBlock® Earplugs (sold separately) into the ear Use twice daily for up to 4 days if needed, or as directed by a doctor Any wax remaining after the 4-day treatment may be ...

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 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 Mack’s® AquaBlock® Earplugs (sold separately) into the ear
  • Use twice daily for up to 4 days if needed, or as directed by a doctor
  • Any wax remaining after the 4-day treatment may be removed by gently rinsing the ear with body-temperature water using the soft rubber bulb ear syringe

Children under 12 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Avoid exposing bottle to excessive heat and direct sunlight
  • Keep cap in bottle when not in use
  • Ear drops foam on contact with earwax due to release of oxygen. There may be a mild crackling sound.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call (586) 427-7560 during business hours (EST)

Product label

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66354-006-80Wax Away Earwax Removal System1 in 1 BOXSOLUTION/ DROPS11
66354-006-80Wax Away Earwax Removal System15 mL in 1 BOTTLESOLUTION/ DROPS151

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
66354-00666354-006-80

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wax Away Earwax Removal SystemCARBAMIDE PEROXIDEMcKeon Products Inc22c6f7db-814b-4e70-9fbe-bbb86385d0702026-02-09WarningsExact identifier
ndc (package): 66354-006-80
ndc (product): 66354-006
ndc11 (package): 66354000680
spl id: 4a637950-a5e8-70d1-e063-6294a90acb51
spl set id: 22c6f7db-814b-4e70-9fbe-bbb86385d070

Reported adverse events (FAERS/openFDA)#

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