QUALITY CHOICE EARWAX REMOVAL DROPS- carbamide peroxide liquid

Quality Choice Earwax Removal Drops by

Drug Labeling and Warnings

Quality Choice Earwax Removal Drops by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Inc., Bell Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Uses

for occasional use as an aid to soften, looser, and remove excessive earwax

Warnings

For use in the ear only

Ask a doctor before use if you have

• 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

avoid contact with the eyes

Stop use and ask a doctor if

• You need to use for more than 4 days
• Excessive earwax remains after use of this product

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 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 titled 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

• Avoid exposing bottle to excessive heat and direct sunlight
• Store bottle in the outer carton
• 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

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

Questions?

1-800-328-5890

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Prestige Brands Inc. owner of the registered trademark Debrox.

Distributed by C.D.M.A., Inc.  43157 W. Nine Mile Novi, MI 48376-0995  www.qualitychoice.com  Questions: 248-449-9300

PRINCIPAL DISPLAY PANEL

Quality Choice Earwax Removal Drops Earwax Removal Aid  Carbamide Peroxide 6.5%  Safe, Gentle, Non-Irritating   0.5 FL OZ (15mL)

Product Labels

INGREDIENTS AND APPEARANCE

QUALITY CHOICE EARWAX REMOVAL DROPS 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-027-16	1 in 1 CARTON	11/27/2014
1		15 mL in 1 BOTTLE, DISPENSING; 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	11/27/2014

Labeler - Chain Drug Marketing Association, Inc. (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
Bell Pharmaceuticals, Inc.		140653770	manufacture(63868-027)