EARWAX REM CVS- carbamide peroxide 6.50% 
CVS

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                                                                   Purpose
Carbamide Peroxide 6.5%......................................................Earwax removal aid

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 eardrum • recently had ear surgery
When using this product avoid contact with the eyes

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

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

Directions
FOR USE IN THE EAR ONLY
adults and children over 12 years of age:
• tilt head sideways • 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 four 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: consult a doctor

Inactive ingredients

Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Glycerin
Mineral Oil
Oxyquinoline Sulfate
Water

image description

EARWAX REM  CVS
carbamide peroxide 6.50% kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-041
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-041-071 in 1 KIT05/14/2010
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 15 mL
Part 1 of 1
EARWAX REM  CVS
carbamide peroxide solution/ drops
Product Information
Item Code (Source)NDC:69842-040
Route of AdministrationTOPICAL
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMOMILE (UNII: FGL3685T2X)  
Glycerin (UNII: PDC6A3C0OX)  
Oxyquinoline Sulfate (UNII: 61VUG75Y3P)  
MINERAL OIL (UNII: T5L8T28FGP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-040-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34405/14/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34405/14/2010
Labeler - CVS (062312574)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(69842-040) , label(69842-040) , pack(69842-041)

Revised: 11/2017
Document Id: 0dc97168-281b-4187-a54a-67eab90d5e3b
Set id: 5a910721-4b33-42f0-b35c-7eea8f7d1898
Version: 2
Effective Time: 20171120
 
CVS