Leader Earwax Removal Drops Earwax Removal Aid 65 mg/mL

CARBAMIDE PEROXIDE · SOLUTION/ DROPS · Cardinal Health, Inc.

No Recall History

Plain English

Leader Earwax Removal Drops Earwax Removal Aid is a solution/ drops containing carbamide peroxide at 65 mg/mL, taken topical. Manufactured by Cardinal Health, Inc..

Key Facts

Brand Name: Leader Earwax Removal Drops Earwax Removal Aid
Generic Name: CARBAMIDE PEROXIDE
NDC Code (Product): 70000-0688
Manufacturer: Cardinal Health, Inc.
Strength: 65 mg/mL
Dosage Form: SOLUTION/ DROPS
Route: TOPICAL
Marketing Status
Application #: M014
Marketing Start: 07/09/2024

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 Leader Earwax Removal Drops Earwax Removal Aid used for?

Leader Earwax Removal Drops Earwax Removal Aid contains CARBAMIDE PEROXIDE. It is a solution/ drops taken topical. Consult your doctor for specific uses.

Is Leader Earwax Removal Drops Earwax Removal Aid a controlled substance?

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

What is the generic name for Leader Earwax Removal Drops Earwax Removal Aid?

The generic name for Leader Earwax Removal Drops Earwax Removal Aid is CARBAMIDE PEROXIDE. There are 12 other brand versions of CARBAMIDE PEROXIDE.

What is the NDC code for Leader Earwax Removal Drops Earwax Removal Aid 65 mg/mL?

The NDC (National Drug Code) for Leader Earwax Removal Drops Earwax Removal Aid 65 mg/mL is 70000-0688, listed by Cardinal Health, Inc..

Product NDC

70000-0688

Package NDC

70000-0688-1

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)