Ear Wax Removal Drops

Ear Wax Removal Drops is an FDA-registered drug product whose active ingredient is CARBAMIDE PEROXIDE - 6.5%. It is labelled by Sheffield Pharmaceuticals LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 11527-143, application M014, label effective 20221206. It is one of 2 FDA drug label records sharing the active ingredient CARBAMIDE PEROXIDE - 6.5%. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CARBAMIDE PEROXIDE - 6.5% are most often described in connection with: aid soften, remove excessive, ear wax. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For occasional use as an aid to soften, loosen and remove excessive ear wax.

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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor.

Warnings Ask a Doctor before use if you have eardrainage, discharge, ear pain,irritation rash in the ear,or are dizzy injury or perforation (hole) of the ear drum Recently had ear surgery

FDA lists 2 drug label records with CARBAMIDE PEROXIDE - 6.5% as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Ear Wax Removal Drops used for?
Uses For occasional use as an aid to soften, loosen and remove excessive ear wax.

Who makes Ear Wax Removal Drops?
Sheffield Pharmaceuticals LLC is the labeler of record for Ear Wax Removal Drops. 2 FDA label records share the active ingredient CARBAMIDE PEROXIDE - 6.5%, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Ear Wax Removal Drops come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Ear Wax Removal Drops prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CARBAMIDE PEROXIDE - 6.5%?
Yes. 2 FDA drug label records list CARBAMIDE PEROXIDE - 6.5% as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Ear Wax Removal Drops been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.