drug facts
1234de19-257c-422c-8706-1239381a2706
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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%)
Medication Information
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
Uses
For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
Purpose
Antihistamine
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
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%)
Active Ingredient
Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)
Ketotifen Fumarate
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
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
Uses
For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
Purpose
Antihistamine
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 (Inactive ingredients)
benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection
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%)
Ketotifen Fumarate (KETOTIFEN FUMARATE)
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