DEBROX- carbamide peroxide liquid 
A-S Medication Solutions

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Debrox Earwax Removal Aid

Drug Facts

Active ingredient

Carbamide peroxide 6.5% non USP*

*pH differs from USP specifications

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

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:

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 PEROXIDE0.065 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
WATER (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: 12/2023
Document Id: a2945c2b-1237-4b87-a4a2-907b60d44589
Set id: 8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1
Version: 10
Effective Time: 20231205
 
A-S Medication Solutions