Ketotifen Fumarate Ophthalmic Solution

Ketotifen Fumarate Ophthalmic Solution is an FDA-registered drug product whose active ingredient is KETOTIFEN FUMARATE. It is labelled by Sentiss Pharmaceuticals LLC taken by ophthalmic and marketed as a human otc drug product. Identifiers on file: NDC 70244-041, application ANDA077958, label effective 20260415. It is one of 12 FDA drug label records sharing the active ingredient KETOTIFEN FUMARATE. 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 KETOTIFEN FUMARATE are most often described in connection with: temporarily relieves, itchy eyes, due pollen, ragweed grass, animal hair. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Directions Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor.

Warnings Do not use if solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation When using this product do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use replace cap after each use Stop use and ask a doctor if you experience any of the following: eye pain changes in vision redness of the eye itching worsens or lasts for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 12 drug label records with KETOTIFEN FUMARATE 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.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Ketotifen Fumarate Ophthalmic Solution used for?
Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Who makes Ketotifen Fumarate Ophthalmic Solution?
Sentiss Pharmaceuticals LLC is the labeler of record for Ketotifen Fumarate Ophthalmic Solution. 12 FDA label records share the active ingredient KETOTIFEN FUMARATE, 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 Ketotifen Fumarate Ophthalmic Solution come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Ketotifen Fumarate Ophthalmic Solution 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 KETOTIFEN FUMARATE?
Yes. 12 FDA drug label records list KETOTIFEN FUMARATE 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 Ketotifen Fumarate Ophthalmic Solution been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.