DEBROX - carbamide peroxide liquid 
GlaxoSmithKline Consumer Healthcare LP

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

Stop use and ask a doctor if

• you need to use for more than four days
• excessive earwax remains after use of this product

When using this product

avoid contact with the eyes

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

• avoid exposing bottle to excessive heat and sunlight
• 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 weekdays

Visit anytime at www.debrox.com

DEBROX is a registered trademark of Aventis Pharmaceuticals, Inc.

Distributed by: GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2009 GlaxoSmithKline

½ FL OZ (15mL)

Used as directed, cleanses the ear with sustained microfoam. Provides a safe, non-irritating method of softening and removing earwax.

#1 DOCTOR & PHARMACIST RECOMMENDED BRAND

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

Debrox®

DROPS

CARBAMIDE PEROXIDE 6.5% NON USP

Earwax Removal Aid

EARWAX REMOVAL AID

#1 DOCTOR & PHARMACIST RECOMMENDED BRAND

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

½ FL OZ (15mL)

DEBROX  carbamide peroxide   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 0135-0091-62 0.7 mL In 1 VIAL None 2 0135-0091-63 15 mL In 1 BOTTLE None 3 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: 11/2010GlaxoSmithKline Consumer Healthcare LP