DEBROX

Dosage form: liquid
Ingredients: CARBAMIDE PEROXIDE 0.065mg in 1mL
Labeler: Medtech Products Inc.
NDC Code: 63029-322

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.

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
  • 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 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 the 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
  • do not store above 77F (25C)
  • store bottle in the outer carton
  • product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound.
  • keep tip on bottle when not in use

Inactive ingredients

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

Questions or comments?

call toll-free 1-866-255-5202 (English/Spanish) weekdays




PRINCIPAL DISPLAY PANEL

Debrox® DROPS
Carbamide Peroxide 6.5% Non USP*
Earwax Removal Aid
Kit includes soft rubber bulb ear syringe and drops
½ FL OZ (15mL)

DEBROX 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-322
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (CARBAMIDE PEROXIDE) CARBAMIDE PEROXIDE0.065 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
SODIUM LAUROYL SARCOSINATE 
SODIUM STANNATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:63029-322-021 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON
17 mL in 1 BOTTLE, DROPPER
2NDC:63029-322-011 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON
215 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34406/01/2012
Labeler - Medtech Products Inc. (122715688)

Revised: 07/2012
 
Medtech Products Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)