LEADER Earwax Removal Kit

Manufacturer: Cardinal Health, 110 dba Leader | Pharma Nobis, LLC
Effective date: 2025-07-28
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: legacy-cache
Hydrated at: 2026-08-01 20:35:29

Label at a glance#

ProductLEADER Earwax Removal Kit

Active ingredientCARBAMIDE PEROXIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

OTC - PURPOSE SECTION

Earwax removal aid

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Ask a doctor before use if you have:

ear drainage or discharge

ear pain, irritation, or rash in ear

recently had ear surgery

dizziness

an injury or perforation of the eardrum

INACTIVE INGREDIENT SECTION

Citric acid

Flavor

Glyrcerin

Propylene glycol

Sodium Lauroyl Sarcosinate

Sodium Stannate

Purified water

DOSAGE & ADMINISTRATION SECTION

tilt head sideways
palce 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 four days if needed, or as directed by a doctor
any wax remaining after treatment may be removed by gently flushing ear with warm water, using a soft rubber bulb ear syringe

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Posion Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Earwax Label 12-30-22Leader Earwax Carton 12-30-22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0490-1	ML - Milliliter	70000-0490	7cce8572-4d8e-48a1-939c-af181108cc68	1	2020-06-05
70000-0490-2	ML - Milliliter	70000-0490	4eba040e-d0a2-4bdf-ac3c-05008edaa710	1	2020-08-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

LEADER Earwax Removal Kit
carbamide peroxide 6.50% kit
SODIUM LAUROYL SARCOSINATE
WATER
ANHYDROUS CITRIC ACID
SODIUM STANNATE
GLYCERIN
PROPYLENE GLYCOL
CARBAMIDE PEROXIDE
HYDROGEN PEROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70000-0490	70000-0490-2, 70000-0490-1

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
Name	UNII	Kind
SODIUM LAUROYL SARCOSINATE	632GS99618	IACT
WATER	059QF0KO0R	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SODIUM STANNATE	NJ7C1V83KG	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CARBAMIDE PEROXIDE	31PZ2VAU81	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3afc6699-36ae-cf26-e063-6294a90ac33b			883d65e1-78ab-be9d-e053-2a95a90aa591	2025-07-28	Warnings	Exact identifier spl id: 3afc6699-36ae-cf26-e063-6294a90ac33b spl set id: 883d65e1-78ab-be9d-e053-2a95a90aa591

Reported adverse events (FAERS/openFDA)#

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