Your browser does not support JavaScript! CVS EARWAX REMOVAL AID (CARBAMIDE PEROXIDE) LIQUID [CVS PHARMACY]
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CVS EARWAX REMOVAL AID (carbamide peroxide) liquid
[CVS Pharmacy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections



Active ingredient                                 Purpose


Carbamide Peroxide 6.5%..........................Earwax Removal Aid




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


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


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 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



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 ingredients

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


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CVS EARWAX REMOVAL AID 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-257
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (CARBAMIDE PEROXIDE) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
SODIUM LAUROYL SARCOSINATE 
SODIUM STANNATE 
PROPYLENE GLYCOL 
CITRIC ACID MONOHYDRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-257-271 in 1 CARTON
115 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34404/25/2011
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 4/2011
 
CVS Pharmacy

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