LEADER EARWAX REMOVAL KIT- carbamide peroxide 6.50% kit liquid

LEADER Earwax Removal Kit by

Drug Labeling and Warnings

LEADER Earwax Removal Kit by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba Leader, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

PURPOSE

Earwax removal aid

INDICATIONS & USAGE

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

WARNINGS

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

Citric acid

Flavor

Glyrcerin

Propylene glycol

Sodium Lauroyl Sarcosinate

Sodium Stannate

Purified water

DOSAGE & ADMINISTRATION

• ​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

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER EARWAX REMOVAL KIT 
carbamide peroxide 6.50% kit liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0490
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	6.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM STANNATE (UNII: NJ7C1V83KG)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0490-2	15 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/06/2019
2	NDC: 70000-0490-1	1 in 1 CARTON	05/06/2019
2		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	05/06/2019

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc		825672884	pack(70000-0490) , label(70000-0490) , manufacture(70000-0490) , analysis(70000-0490)