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Debrox
carbamide peroxide · Debrox is an over-the-counter drug containing carbamide peroxide, made by Medtech Products Inc..
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Auricular (Otic)
- Manufacturers
- 1
- + 1 repackager labels
For occasional use as an aid to soften, loosen, and remove excessive earwax
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing07/22/2026CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB...Bell Pharmaceuticals, Inc · 11 products · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs...
- Class IIDrugOngoing04/26/2023Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC...Pharma Nobis LLC · CGMP Deviations: active ingredient may be subpotent before the...
- Class IIDrug08/17/2022Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc....Mckesson Medical-Surgical Inc. Corporate Office · CGMP Deviations: products were stored outside the drug label...
- Class IIIDrug01/30/2013Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778...Axcentria Pharmaceuticals LLC · Stability data does not support expiration date: Stability data...
Active ingredients
Carbamide peroxide 6.5% non USP
Purpose
Earwax removal aid
Uses
For occasional use as an aid to soften, loosen, and remove excessive earwax
Directions
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
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
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
You need to use for more than four days excessive earwax remains after use of this product
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Inactive ingredients
Citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water
Questions?
1-866-255-5202 Debrox.com
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Liquid | 65 mg/mL | auricular (otic) | 2 |
Manufacturers and labels
2 FDA labels · 1 from repackagers
- Medtech Products Inc.Shown hereM014 · Label 01/27/2025 · NDC 63029-321Full label
Repackager labels (1)
- A-S Medication Solutions09/03/2025
Debrox: common questions
- What is Debrox used for?
- For occasional use as an aid to soften, loosen, and remove excessive earwax
- Is Debrox a prescription drug?
- No. Debrox is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Debrox?
- Yes. Other FDA-listed products with the same active ingredients include Ear Wax Removal Aid Drops, Earwax Removal Drops, Ear Wax Removal Drops, ear drops.
- Who makes Debrox?
- Medtech Products Inc. lists Debrox with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 09/03/2025 · Label text is shown as published by the manufacturer. Not medical advice