Eye Itch Relief
Eye Itch Relief is an FDA drug label for the active ingredient KETOTIFEN FUMARATE manufactured by TOPCO ASSOCIATES LLC administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231208.
Generic: KETOTIFEN FUMARATE
Manufacturer: TOPCO ASSOCIATES LLC
Product Type: HUMAN OTC DRUG
Route: OPHTHALMIC
Dosage Form:
NDC: 36800-097
Application: NDA021996
Effective: 20231208
Active Ingredients: Active ingredient Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)
Indications & Usage
Uses for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
Dosage & Administration
Directions ▪ adults and children 3 years and older: ▪ put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day ▪ if using other ophthalmic products while using this product, wait at least 5 minutes between each product ▪ children under 3 years of age: consult a doctor
Contraindications
Not available.
Warnings
Warnings For external use only Do not use • if you are sensitive to any ingredient in this product • if solution changes color or becomes cloudy • to treat contact lens related irritation When using this product • remove contact lenses before use • wait at least 10 minutes before re-inserting contact lenses after use • do not touch tip of container to any surface to avoid contamination • 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 eyes • itching that 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.
Adverse Reactions
Not available.
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