CVS EARWAX REMOVAL AID- carbamide peroxide liquid

CVS Earwax Removal Aid by

Drug Labeling and Warnings

CVS Earwax Removal Aid by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. 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.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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 ear drum
- recently had ear surgery

Stop use and ask a doctor if
- you need to use for more than four days
- excessive wax remains after use of this product

When using this product - avoid contact with the eyes

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

DOSAGE & ADMINISTRATION

Directions
FOR USE IN THE EAR ONLY
Unscrew cap from bottle. Remove foil safety seal from bottle. Affix applicator cap to bottle.

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 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 may be removed by gently flushing the ear with warm water, using a soft rubber ear syringe.

Children under 12 years of age: consult a doctor.

Other information
- avoid exposing the bottle to excessive heat and direct sunlight
- keep cap on bottle when not in use
- Note: Drops foam on contact with ear wax due to release of oxygen. There may be an associated "cracking" sound
- Note: Oversize packaging for ease in reading label information. Contains one bottle.
- Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

INACTIVE INGREDIENT

Inactive ingredients

glycerin, propylene glycol, purified water, sodium lauroyl sarcosinate, citric acid, flavor, sodium stannate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS EARWAX REMOVAL AID 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-257
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SODIUM STANNATE (UNII: NJ7C1V83KG)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-257-27	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	04/25/2011

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture