Active Ingredient
Carbamide peroxide 6.5% non USP
Debrox Liquid
FDA Label NDC 63029-321
12 label sections · Submitted to the FDA by Medtech Products Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Debrox (NDC 63029-321). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Earwax removal aid
Uses
For occasional use as an aid to soften, loosen, and remove excessive earwax
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 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, in an upright position
- 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?
1-866-255-5202 Debrox.com
Principal Display Panel
Debrox Earwax Removal Aid 0.5 FL OZ (15 mL)
Debrox Earwax Removal Aid 0.5 Fl Oz (15 mL) (Debrox 63029 321 01 01)
Debrox Earwax Removal Kit 0.5 FL OZ (15 mL)
Debrox Earwax Removal Kit 0.5 Fl Oz (15 mL) (Debrox 63029 321 01 02)
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