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Ketotifen Fumarate

Dosage form
SOLUTION/ DROPS
Labeler
Rugby Laboratories
Label updated
2026-03-20
Retrieved
2026-09-07
Active ingredients
See original label
View original label and images on DailyMed ↗
Active ingredient

Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)

Purpose

Antihistamine

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

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 a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • redness of the eyes
  • itching that worsens or lasts for more than 72 hours

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 and older:
    • put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
    • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
  • 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

Questions or comments?

[phone icon] Call: 1-844-677-8429

Distributed by:
RUGBY ®LABORATORIES
Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com
Product of Italy

9690003

AK60107

Package/Label Principal Display Panel

[Image in the official label — see DailyMed source]

Rugby ® NDC 0536-1252-40

compare to

Systane ZADITOR

active ingredient*

eye itch relief

ketotifen fumarate

ophthalmic solution, 0.035%

ANTIHISTAMINE EYE DROPS

up to 12 hours

  • works in minutes
  • original prescription
    strength
  • for ages 3 years and older

0.17 FL OZ (5 mL) Sterile

DailyMed Set ID: 8aa81ae9-112a-49fa-a0cb-ed0217a40de5 · Version 4
NDC: 0536-1252