DEBROX - carbamide peroxide liquid
GlaxoSmithKline Consumer Healthcare LP

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.

----------

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
irritation or rash in the ear
an injury or perforation (hole) of the eardrum
recently had ear surgery
ear pain
dizziness

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 77°F (25°C)
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 1-800-245-1040 (English/Spanish) weekdays

For more information on Debrox, visit essentialsforlivingwell.com

Debrox® is a registered trademark of Aventis Pharmaceuticals Inc licensed to the GlaxoSmithKline group of companies.

Distributed by: GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

When used as directed, Debrox cleanses the ear with microfoam action providing a safe, non-irritating method of softening and removing earwax.

Note: Oversize package for ease in reading label information.

Important: This package has been overwrapped for your protection. Do not use if plastic overwrap printed “Sealed For Your Protection” is disturbed or missing.

Principal Display Panel

NDC 0135-0091-63

Debrox®

DROPS

CARBAMIDE PEROXIDE 6.5% NON USP*

Earwax Removal Aid

OTC Master's Circle 2010 Achievement Award

#1 Pharmacist Recommended Brand! Pharmacy Times

Safe, gentle, non-irritating
Easily cleanses ear with microfoam action

½ FL OZ (15mL)

28636XE

Debrox 0.5 fl oz (15 mL) carton

DEBROX
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0091
Route of Administration	AURICULAR (OTIC)	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (CARBAMIDE PEROXIDE)	CARBAMIDE PEROXIDE	0.065 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
PROPYLENE GLYCOL
SODIUM LAUROYL SARCOSINATE
SODIUM STANNATE
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0135-0091-70	10 VIAL ( VIAL) in 1 CARTON	contains a VIAL (0135-0091-62)
1	NDC:0135-0091-62	0.7 mL in 1 VIAL	This package is contained within the CARTON (0135-0091-70)
2	NDC:0135-0091-63	15 mL in 1 BOTTLE	None
3	NDC:0135-0091-59	15 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	11/08/2010

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 10/2011 GlaxoSmithKline Consumer Healthcare LP