DEBROX- carbamide peroxide liquid 
Proficient Rx LP

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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 (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 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 25C (77F)
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   Debrox.com

PRINCIPAL DISPLAY PANEL

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

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

71205-136-15
DEBROX 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-136(NDC:63029-322)
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 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:71205-136-151 in 1 CARTON10/01/2018
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 DrugM01406/01/2012
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022RELABEL(71205-136)

Revised: 1/2024
Document Id: a633e28e-2d9d-4a7b-81ea-416efc368bd9
Set id: e1dacadf-cfb4-4a06-9858-dd6fba2975f8
Version: 4
Effective Time: 20240101
 
Proficient Rx LP