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Ketotifen Fumarate Ophthalmic Solution

Dosage form
SOLUTION/ DROPS
Labeler
Sentiss Pharmaceuticals LLC
Label updated
2026-04-15
Retrieved
2026-09-07
Active ingredients
See original label
View original label and images on DailyMed ↗
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 ifyou 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: Sentiss Pharmaceuticals, LLC
San Clemente, CA 92672 (USA)

Manufactured by: Ophtapharm AG, Riethofstrasse 1,
Hettlingen, 8442, Switzerland (CHE) 

Made in Switzerland

Packaging

[Image in the official label — see DailyMed source]

DailyMed Set ID: 7e7be193-63ec-474d-a596-e22fc8b1be0f · Version 1
NDC: 70244-041