Ear Wax Removal System

Dosage form: liquid
Ingredients: CARBAMIDE PEROXIDE 6.5g in 100mL
Labeler: CVS Pharmacy
NDC Code: 59779-561

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.

CVS Pharmacy, Inc. Ear Wax Removal System Drug Facts

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

Fast Acting

EARWAX REMOVAL SYSTEM

REMOVAL AID

CARBAMIDE PEROXIDE 6.5%

Complete 2-step system

EARWAX REMOVAL AID

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 
SUCCINIC ANHYDRIDE 
Packaging
#Item CodePackage Description
1NDC:59779-561-051 BOTTLE 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: 04/2013
 
CVS Pharmacy

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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