EARWAX REM CVS- carbamide peroxide 6.50% kit

EARWAX REM by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                   Purpose
Carbamide Peroxide 6.5%......................................................Earwax removal aid

PURPOSE

Uses

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

WARNINGS

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 OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

DOSAGE & ADMINISTRATION

Directions
FOR USE IN THE EAR ONLY
adults and children over 12 years of age:
tilt head sideways 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 four 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

INACTIVE INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EARWAX REM  CVS
carbamide peroxide 6.50% kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-041

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-041-07	1 in 1 KIT	05/14/2010

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

Part 1 of 1

EARWAX REM  CVS
carbamide peroxide solution/ drops

Product Information
Item Code (Source)	NDC: 69842-040
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: 69842-040-01	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	05/14/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	05/14/2010

Labeler - CVS (062312574)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(69842-040) , label(69842-040) , pack(69842-041)