FDA.reportPublic FDA data

Leader Earwax Removal Kit Earwax Removal Aid and Bulb

Manufacturer
Cardinal Health 110 DBA Leader
Effective date
2024-08-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:17:07

Label at a glance#

ProductLeader 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 warm water,...

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 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 15-30ºC (59-86ºF)
  • 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
Weekdays 8:30-5:00 CST

package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelInner labelInner labelLabel kitLabel kit

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
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
70000-0688-1Leader Earwax Removal Kit Earwax Removal Aid and Bulb15 mL in 1 BOTTLESOLUTION/ DROPS15 mL65 mg in 1mL2
70000-0688-1Leader Earwax Removal Kit Earwax Removal Aid and Bulb1 in 1 BOXSOLUTION/ DROPS65 mg in 1mL2
70000-0689-1Leader Earwax Removal Kit Earwax Removal Aid and Bulb1 in 1 BOXKIT12
70000-0689-1Leader Earwax Removal Kit Earwax Removal Aid and Bulb1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0688LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB (CARBAMIDE PEROXIDE) KIT [CARDINAL HEALTH 110 DBA LEADER]2Current NDC20240814_36c1408b-4287-4e9f-aa17-4f05add50038.zip
70000-0689LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB (CARBAMIDE PEROXIDE) KIT [CARDINAL HEALTH 110 DBA LEADER]2Current NDC, 4 package rows20240814_36c1408b-4287-4e9f-aa17-4f05add50038.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
70000-068970000-0689-1
70000-068870000-0688-1

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
Leader Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDECardinal Health, Inc.0022a174-8377-44af-84a9-31adb27de1312024-08-23WarningsExact identifier
ndc (package): 70000-0688-1
ndc (product): 70000-0688
ndc11 (package): 70000068801
Leader Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDECardinal Health 110 DBA Leader36c1408b-4287-4e9f-aa17-4f05add500382024-08-12WarningsExact identifier
ndc (package): 70000-0688-1
ndc (package): 70000-0689-1
ndc (product): 70000-0689
ndc11 (package): 70000068801
ndc11 (package): 70000068901
spl id: 1f7f89ab-ef7d-21dc-e063-6294a90ab82a
spl set id: 36c1408b-4287-4e9f-aa17-4f05add50038

Reported adverse events (FAERS/openFDA)#

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