DEBROX- carbamide peroxide liquid 
Medtech Products Inc.

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.

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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

Debrox Earwax Removal Aid 0.5 FL OZ (15 mL)

Debrox Earwax Removal Aid 0.5 FL OZ (15 mL) Carton

DEBROX 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:63029-321-011 in 1 CARTON08/01/2012
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 finalpart34408/01/2012
Labeler - Medtech Products Inc. (122715688)

Revised: 12/2017
Document Id: 14e26db0-7a5e-4f95-8ee3-9c7174410f96
Set id: 43649ba3-75e0-4dcf-9172-23767dbaeda6
Version: 1
Effective Time: 20171205
 
Medtech Products Inc.