Debrox
Carbamide Peroxide · Liquid · Auricular (otic)
Active ingredient
Active ingredient Carbamide peroxide 6.5% non USP
Purpose
Purpose Earwax removal aid
Uses
Uses For occasional use as an aid to soften, loosen, and remove excessive earwax
Warnings
Warnings 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
Ask a doctor before use
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
When using this product avoid contact with the eyes
Stop use and 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 (1-800-222-1222) right away.
Directions
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
Inactive ingredients
Inactive Ingredients citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water
Questions?
Questions? 1-866-255-5202 Debrox.com
Label text from the FDA structured product label by Medtech Products Inc. (revised Jan 27, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Carbamide Peroxide in 2 products
Debrox NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-4201 | Carbamide Peroxide 65 mg/mL Liquid | A-S Medication Solutions | OTC MONOGRAPH DRUG |
| 63029-321 | Carbamide Peroxide 65 mg/mL Liquid | Medtech Products Inc. | OTC MONOGRAPH DRUG |
Debrox recalls
- D-1318-2022 Aug 17, 2022 · Class II · Terminated
CGMP Deviations: products were stored outside the drug label specifications.
Frequently asked questions
What is Debrox used for?
Uses For occasional use as an aid to soften, loosen, and remove excessive earwax
Who makes Debrox?
Debrox is listed by 2 labelers in the FDA NDC directory, including A-S Medication Solutions, Medtech Products Inc..
Has Debrox been recalled?
The FDA enforcement database lists 1 recall for Debrox, most recently D-1318-2022 (class ii): CGMP Deviations: products were stored outside the drug label specifications.