Earwax Removal by Apothecary Products, LLC / Continental Manufacturing Chemist, Inc. EARWAX REMOVAL liquid

Earwax Removal by

Drug Labeling and Warnings

Earwax Removal by is a Otc medication manufactured, distributed, or labeled by Apothecary Products, LLC, Continental Manufacturing Chemist, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

 Carbamide Peroxide 6.5%

Purpose

Earwax Removal Aid

Use(s)

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

Warnings

Warning

 For External Use Only

Do not use

•  In the eye
• for more than 4 days

Ask a doctor before use if you have

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

Stop use and ask a doctor if

 Stop use and ask a doctor if excessive earwax remains after use

Keep out of reach of children

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

Directions

 FOR USE IN THE EAR ONLY

Adults and children 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 my be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.  Children under 12 years of age, consult a doctor.

Other information

 Do not use if imprinted seal on cap is broken or missing.

Storage

• Store at controlled room temperature 15 to 30C (59 to 86F)
• KEEP IN A DRY PLACE

Principal Display Panel

 Principle display panel:

Flents Earwax Removal Kit Box

Inactive Ingredients

 anhydrous Glycerin

Questions or Comments?

Call 1-800-328-2742

INGREDIENTS AND APPEARANCE

EARWAX REMOVAL 
earwax removal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49762-450
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	120.0 mg  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49762-450-15	15 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part344	08/31/2008

Labeler - Apothecary Products, LLC (092312735)

Registrant - Continental Manufacturing Chemist, Inc. (005278007)