EAR WAX REMOVAL SYSTEM RITE AID- carbamide peroxide - 6.50% 
Rite Aid

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

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

image descriptionimage description

EAR WAX REMOVAL SYSTEM  RITE AID
carbamide peroxide - 6.50% kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1225
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1225-71 in 1 KIT10/07/2011
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 15 mL
Part 1 of 1
EAR WAX REMOVAL DROPS  RITE AID
carbamide peroxide - 6.50% solution/ drops
Product Information
Item Code (Source)NDC:11822-1226
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:11822-1226-115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34410/07/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34410/07/2011
Labeler - Rite Aid (014578892)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(11822-1226) , pack(11822-1225)

Revised: 6/2018
Document Id: 3f3b722a-07e0-40eb-8c19-16a8f2137011
Set id: 0a7e2ef1-14a0-44b0-a9ca-0db89b8efbc4
Version: 1
Effective Time: 20180613
 
Rite Aid