EAR WAX RMVL CVS- carbamide peroxide 6.5% liquid 

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.


Drug Facts

Active ingredient                        Purpose

Carbamide peroxide  6.5%          Earwax removal aid


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


Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

When using this product avoid contact with eyes

Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product

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

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

DirectionsFor 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
Children under 12 years of age: consult a doctor.

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

image description

carbamide peroxide 6.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-039
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide Peroxide (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) Carbamide Peroxide6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Lauroyl Sarcosinate (UNII: 632GS99618)  
Sodium Stannate (UNII: NJ7C1V83KG)  
Water (UNII: 059QF0KO0R)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-039-011 in 1 CARTON12/24/2014
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34412/24/2014
Labeler - CVS (062312574)
Registrant - Product Quest Mfg. (927768135)
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(69842-039) , label(69842-039)

Revised: 11/2017
Document Id: 5e49a43a-a39c-44e1-a373-187d52d26d10
Set id: 6d677dc4-3c05-451f-9918-33323667cc90
Version: 2
Effective Time: 20171120