Ketotifen Fumarate
- Dosage form
- SOLUTION/ DROPS
- Labeler
- A-S Medication Solutions
- Label updated
- 2023-05-11
- Retrieved
- 2026-09-07
- Active ingredients
- See original label
Active ingredient
Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)
Purpose
Antihistamine
Uses
For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
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 doctor if you experience any of the following:
-
▪ eye pain -
▪ changes in vision -
▪ redness of the eyes -
▪ itching that worsens or lasts more than 72 hours
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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.
Children under 3 years of age: consult a doctor
Other Information
Store at 4-25°C (39-77°F)
Inactive ingredients
benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection
Questions or comments?
Toll Free Product Information
Call: 1-800-645-2158
Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive
Suite 233, Livonia, MI 48152
www.rugbylaboratories.com
Product of Italy
HOW SUPPLIED
Product: 50090-6472
NDC: 50090-6472-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON
KETOTIFEN FUMARATE
[Image in the official label — see DailyMed source]
DailyMed Set ID: 1234de19-257c-422c-8706-1239381a2706 · Version 1
NDC: 50090-6472