ketotifen fumarate

FDA Drug Profile — Eye Itch Relief, Equate Eye Itch Relief, Zaditor

Drug Details

Generic Name
ketotifen fumarate
Brand Names
Eye Itch Relief, Equate Eye Itch Relief, Zaditor
Application Number
NDA021996
Sponsor
Kroger Company
NDC Codes
7
Dosage Forms
SOLUTION/ DROPS, SOLUTION
Routes
OPHTHALMIC
Active Ingredients
KETOTIFEN FUMARATE

Indications and Usage

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

Warnings

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.