Drugplain

Earwax Removal Drops .065 mg/mL

Carbamide Peroxide 6.5% · LIQUID · Humco Holding Group, Inc

No Recall History
Plain English

Earwax Removal Drops is a liquid containing carbamide peroxide 6.5% at .065 mg/mL, taken auricular (otic). Manufactured by Humco Holding Group, Inc.

Key Facts

Brand Name
Earwax Removal Drops
Generic Name
Carbamide Peroxide 6.5%
NDC Code (Product)
0395-9133
Manufacturer
Humco Holding Group, Inc
Strength
.065 mg/mL
Dosage Form
LIQUID
Route
AURICULAR (OTIC)
Marketing Status
Application #
M014
Marketing Start
06/04/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

diarrhoea14 reports
chronic kidney disease9 reports
pneumonia9 reports
fatigue8 reports
pyrexia8 reports
abdominal pain7 reports
blood creatinine increased7 reports
haemoglobin decreased7 reports
acute kidney injury6 reports
anxiety6 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 and 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 4 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 For use in the ear only 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 ear drum 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 4 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.

Frequently Asked Questions

What is Earwax Removal Drops used for?

Earwax Removal Drops contains Carbamide Peroxide 6.5%. It is a liquid taken auricular (otic). Consult your doctor for specific uses.

Is Earwax Removal Drops a controlled substance?

Earwax Removal Drops is not classified as a controlled substance by the DEA.

What is the generic name for Earwax Removal Drops?

The generic name for Earwax Removal Drops is Carbamide Peroxide 6.5%. There are 10 other brand versions of Carbamide Peroxide 6.5%.

What is the NDC code for Earwax Removal Drops .065 mg/mL?

The NDC (National Drug Code) for Earwax Removal Drops .065 mg/mL is 0395-9133, listed by Humco Holding Group, Inc.

Product NDC

0395-9133

Package NDC

0395-9133-45

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)