DEBROX carbamide peroxide CARBAMIDE PEROXIDE HYDROGEN PEROXIDE CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL SODIUM LAUROYL SARCOSINATE SODIUM STANNATE WATER
Drug Facts
Composition & Profile
Identifiers & Packaging
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 Debrox 0.5 fl oz carton
- 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 Debrox 0.5 fl oz carton
Overview
Uses for occasional use as an aid to soften, loosen and remove excessive earwax
Indications & Usage
Uses for occasional use as an aid to soften, loosen and remove excessive earwax
Dosage & Administration
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
Warnings & Precautions
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.
Purpose
Purpose Earwax removal aid
When Using
When using this product avoid contact with the eyes
Stop Use & Ask a Doctor
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 Out of Reach of Children
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Storage & Handling
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
Questions
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.
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