Ketotifen Fumarate Ophthalmic Solution
- Dosage form
- SOLUTION/ DROPS
- Labeler
- Armas Pharmaceuticals Inc.
- Label updated
- 2024-01-01
- 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
Packaging
[Image in the official label — see DailyMed source]
DailyMed Set ID: b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3 · Version 4
NDC: 72485-617