EAR WAX REMOVAL SYSTEM- carbamide peroxide liquid 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Uses

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

Warnings

For use in the ear only

Do not use:

•
if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; ask a doctor
•
if you have an injury or perforation (hole) of the eardrum or after ear surgery unless directed by a doctor
•
for more than 4 days

When using this product

avoid contact with the eyes.

Stop use and ask a doctor if

excessive earwax remains after use of this product for 4 consecutive days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

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 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 bulb ear syringe
•
when the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal
•
children under 12 years of age: ask a doctor

Other information

•
store at 20°-25°C (68°-77°F)
•
protect from heat or direct sunlight
•
keep cap tightly on bottle when not in use
•
product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound.

Inactive ingredients

acetaminophen, alcohol, butylated hydroxyanisole, edetate disodium, glycerin, propyl gallate, sodium stannate, succinic anhydride

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredient in Murine® Ear Wax Removal System

CARBAMIDE PEROXIDE 6.5%

EAR WAX REMOVAL SYSTEM

FAST ACTING

EAR WAX REMOVAL AID

an approved system to safely remove ear wax

SYRINGE AND DROPS INCLUDED

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

Ear Wax Removal System Carton Image 1

Ear Wax Removal System Carton Image 1

Ear Wax Removal System Carton Image 2

Ear Wax Removal System Carton Image 2

EAR WAX REMOVAL SYSTEM 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-561
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACETAMINOPHEN 
ALCOHOL 
BUTYLATED HYDROXYANISOLE 
EDETATE DISODIUM 
GLYCERIN 
PROPYL GALLATE 
SODIUM STANNATE 
Packaging
#Item CodePackage Description
1NDC:59779-561-051 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34406/08/2005
Labeler - CVS Pharmacy (062312574)

Revised: 09/2012
Document Id: 433f9200-c77c-4746-96ce-13e40191060e
Set id: 433f9200-c77c-4746-96ce-13e40191060e
Version: 1
Effective Time: 20120920
 
CVS Pharmacy