DEBROX- carbamide peroxide liquid 
A-S Medication Solutions

----------

DEBROX 63029-321-01

Debrox Earwax Removal Aid

Drug Facts

Active ingredient

Carbamide peroxide 6.5% non USP

Purpose

Earwax removal aid

Uses

For occasional use as an aid to soften, loosen, and remove excessive earwax

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 earwax 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 (1-800-222-1222) 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 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

Other information

Inactive Ingredients

citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water

Questions?

1-866-255-5202  Debrox.com

HOW SUPPLIED

Product: 50090-4201

NDC: 50090-4201-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

Carbamide Peroxide

Label Image
DEBROX 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4201(NDC:63029-321)
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
AQUA (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-4201-01 in 1 CARTON03/19/2019
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01408/01/2012
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-4201)

Revised: 9/2025
Document Id: b34a6756-91f6-448d-be3f-a40632075df0
Set id: 8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1
Version: 13
Effective Time: 20250903
 
A-S Medication Solutions