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
Cardinal Health
NDC Codes
7
Dosage Forms
SOLUTION, SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
KETOTIFEN FUMARATE

Indications and Usage

Uses For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

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