EAR WAX REMOVAL SYSTEM- carbamide peroxide - 6.50% 
Walmart

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 Kit 13-243PQ



Step 1 Ear Wax Removal Drops

Active ingredient                              Purpose

Carbamide Peroxide - 6.50%             Earwax removal aid

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

Warnings
For external use only

Keep out of reach of the children

If product is 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 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.

Other information

• Protect from heat and direct sunlight • Keep cup on bottle when not in use

Inactive ingredient

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

Questions or comments?
1-866-483-2846

image descriptionimage description

EAR WAX REMOVAL SYSTEM 
carbamide peroxide - 6.50% kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-554
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-554-071 in 1 KIT08/15/2014
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 15 mL
Part 1 of 1
EAR WAX REMOVAL DROPS   WELL AT WALGREENS
carbamide peroxide - 6.50% solution/ drops
Product Information
Item Code (Source)NDC:49035-552
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:49035-552-0115 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34408/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34410/04/2011
Labeler - Walmart (051957769)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(49035-552) , pack(49035-554)

Revised: 1/2018
Document Id: 61cc4d9f-26ea-190a-e053-2991aa0a1d9f
Set id: ea835ce6-4413-4bf3-8ce8-89a3489a7dbf
Version: 3
Effective Time: 20180102
 
Walmart