CVS 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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EarWax Removal Drops

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 ear wax

Warnings

Ask a doctor before use if you have

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

Keep this and all drugs out of the reach of children.

If swallowed, get medical help or contact a Posion Control Center right away.

Directions

​FOR USE IN THE EAR ONLY

adults and children over 12 years of age:

​children under 12 years: consult a doctor

Other information

Inactive ingredients

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

image description

CVS EARWAX REM  CVS
carbamide peroxide 6.50% kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-042
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-042-071 in 1 KIT11/12/2014
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 15 mL
Part 1 of 1
EARWAX REMOVAL 
carbamide peroxide 6.50% solution/ drops
Product Information
Item Code (Source)NDC:69842-043
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:69842-043-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart344
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34411/12/2014
Labeler - CVS (062312574)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(69842-042, 69842-043) , label(69842-042, 69842-043)

Revised: 11/2017
Document Id: 07b0bb01-eb45-4646-a599-0df2b73aabd7
Set id: bd844af4-fbf0-459b-823d-b2a675f90c19
Version: 2
Effective Time: 20171120
 
CVS