EAR DROPS- carbamide peroxide 6.5% liquid 
Good Sense

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


Do not 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

Keep out of reach of children

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:50804-508
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:50804-508-011 in 1 CARTON09/01/2017
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 finalpart34409/01/2017
Labeler - Good Sense (076059836)
Registrant - Product Quest Mfg. (927768135)
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(50804-508) , label(50804-508)

Revised: 8/2018
Document Id: a4dee829-eeb9-49b9-855e-c0531f115fc8
Set id: e828c3d4-219e-4c94-b962-267bcf12e930
Version: 1
Effective Time: 20180810
Good Sense