Drug Facts
1234de19-257c-422c-8706-1239381a2706
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)
Purpose
Antihistamine
How Supplied
Product: 50090-6472 NDC: 50090-6472-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON
Medication Information
Purpose
Antihistamine
How Supplied
Product: 50090-6472
NDC: 50090-6472-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON
Description
Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)
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
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
Active Ingredient
Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)
Other Information
Store at 4-25°C (39-77°F)
Ketotifen Fumarate
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
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
-
▪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.
Structured Label Content
Uses
For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
Purpose
Antihistamine
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
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
How Supplied (HOW SUPPLIED)
Product: 50090-6472
NDC: 50090-6472-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON
Active Ingredient (Active ingredient)
Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)
Other Information
Store at 4-25°C (39-77°F)
Ketotifen Fumarate (KETOTIFEN FUMARATE)
Inactive Ingredients (Inactive ingredients)
benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection
Questions Or Comments? (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
When Using This Product (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 (Stop use and ask doctor if)
-
▪eye pain
-
▪changes in vision
-
▪redness of the eyes
-
▪itching that worsens or lasts more than 72 hours
Keep Out of Reach of Children. (Keep out of reach of children.)
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:00:47.208400 · Updated: 2026-03-14T23:01:09.685872