Drugplain

DEBROX 65 mg/mL

Carbamide Peroxide · LIQUID · Medtech Products Inc.

1 Recall on Record
Plain English

Debrox is an over-the-counter ear drop containing carbamide peroxide that helps soften and remove earwax buildup from the ear canal. The liquid solution works by breaking down earwax through a gentle bubbling action.

Key Facts

Brand Name
DEBROX
Generic Name
Carbamide Peroxide
NDC Code (Product)
63029-321
Manufacturer
Medtech Products Inc.
Strength
65 mg/mL
Dosage Form
LIQUID
Route
AURICULAR (OTIC)
Marketing Status
Application #
M014
Marketing Start
08/01/2012

Recall History

1 Recall on Record
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

glossodynia1,632 reports
pemphigus1,613 reports
hand deformity1,604 reports
joint swelling1,594 reports
infusion related reaction1,589 reports
helicobacter infection1,582 reports
impaired healing1,581 reports
irritable bowel syndrome1,574 reports
systemic lupus erythematosus1,570 reports
pericarditis1,561 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 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

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

Frequently Asked Questions

What is DEBROX used for?

Debrox is an over-the-counter ear drop containing carbamide peroxide that helps soften and remove earwax buildup from the ear canal. The liquid solution works by breaking down earwax through a gentle bubbling action.

Is DEBROX a controlled substance?

DEBROX is not classified as a controlled substance by the DEA.

What is the generic name for DEBROX?

The generic name for DEBROX is Carbamide Peroxide. There are 11 other brand versions of Carbamide Peroxide.

What is the NDC code for DEBROX 65 mg/mL?

The NDC (National Drug Code) for DEBROX 65 mg/mL is 63029-321, listed by Medtech Products Inc..

Product NDC

63029-321

Package NDC

63029-321-01

Other Carbamide Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)