DEBROX

GlaxoSmithKline Consumer Healthcare LP

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• DEBROX Uses
• Warnings
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
  • Keep this and all drugs out of the reach of children.
• Directions
• DEBROX Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient

Carbamide peroxide 6.5% non USP*

*pH differs from USP specifications

Purpose

Earwax removal aid

DEBROX 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

DEBROX 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 Debrox.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

Made in Canada

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

2011Master's Circle Award

#1 Pharmacist Recommended Brand! Pharmacy Times

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

½ FL OZ (15mL)

©2012 GlaxoSmithKline

28636XF