Ketotifen Fumarate Ophthalmic Solution
- Dosage form
- SOLUTION/ DROPS
- Labeler
- Preferred Pharmaceuticals Inc.
- Label updated
- 2026-03-18
- Retrieved
- 2026-09-07
- Active ingredients
- See original label
Label information
Drug Facts
Active ingredient
Ketotifen (0.025%)
(equivalent to Ketotifen Fumarate 0.035%)
Purpose
Antihistamine
Use
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
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
Label information
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
-
• Adults and children 3 years of age 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
-
• Only for use in the eye. -
• Store at 20° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].
Inactive ingredients
Benzalkonium Chloride 0.01%; Glycerin and Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).
Questions?
call toll-free 1-855-473-6847,weekdays, 7:00 AM - 5:30 PM CT
Label information
Now OTC!
ANTIHISTAMINE EYE DROPS
UPTO 12 HOURS EYE ITCH RELIEF
• Works in Minutes
• Original Prescription Strength
FOR AGES 3 YEARS AND OLDER
30 DAY SUPPLY
Sterile
Original Prescription Strength
Do not use if seal on bottle is missing or broken.
FOR TOPICAL OPHTHALMIC USE ONLY.
PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.
Distributed by: Armas Pharmaceuticals, Inc.
Freehold, NJ 07728 (USA)
Manufactured by: Ophtapharm AG, Riethofstrasse 1,
Hettlingen, 8442, Switzerland (CHE) for Sentiss
Made in Switzerland
Relabeled By: Preferred Pharmaceuticals Inc.
NDC 68788-4084-5
Packaging
[Image in the official label — see DailyMed source]
DailyMed Set ID: f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c · Version 2
NDC: 68788-4084