DEBROX- carbamide peroxide liquid 
Denison Pharmaceuticals, LLC.

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

  • 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, 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

½ FL OZ (15mL)

PRINCIPAL DISPLAY PANEL Debrox DROPS Carbamide Peroxide 6.5% Non USP* Earwax Removal Aid ½ FL OZ (15mL)

DEBROX 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1224
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:0295-1224-021 in 1 CARTON01/01/201703/11/2019
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 finalpart34401/01/201703/11/2019
Labeler - Denison Pharmaceuticals, LLC. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC.001207208manufacture(0295-1224)

Revised: 3/2019
Document Id: 83d2c20e-a3d5-4133-e053-2991aa0a51ce
Set id: 3ee914a2-25b9-4d74-9c89-74345cee0762
Version: 4
Effective Time: 20190311
 
Denison Pharmaceuticals, LLC.