CVS EARWAX REM CVS- carbamide peroxide 6.50% kit

CVS EARWAX REM by

Drug Labeling and Warnings

CVS EARWAX REM by is a Otc medication manufactured, distributed, or labeled by CVS, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Carbamide Peroxide 6.5%

Purpose

Earwax removal aid

Uses

for occasional use as an aid to soften, loosen and remove excessive ear wax

Warnings

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 eardrum
• 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 four days
• excessive ear wax remains after use of this product

Keep this and all drugs out of the reach of children.

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

Directions

​FOR USE IN THE EAR ONLY

adults and children over 12 years of age:

• ​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

​children under 12 years: consult a doctor

Other information

• store bottle in the outer carton
• product foams on contact with ear wax due to release of oxygen. There may be an associated "cracklling" sound.
• keep cap on bottle when not in use 

Inactive ingredients

Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Glycerin
Mineral Oil
Oxyquinoline Sulfate
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS EARWAX REM  CVS
carbamide peroxide 6.50% kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-042

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-042-07	1 in 1 KIT	11/12/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	15 mL

Part 1 of 1

EARWAX REMOVAL 
carbamide peroxide 6.50% solution/ drops

Product Information
Item Code (Source)	NDC: 69842-043
Route of Administration	TOPICAL

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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
GLYCERIN (UNII: PDC6A3C0OX)
OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-043-01	15 mL in 1 BOTTLE; 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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	11/12/2014

Labeler - CVS (062312574)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(69842-042, 69842-043) , label(69842-042, 69842-043)