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Ketotifen Fumarate

OTC Ophthalmic RxCUI 311237
Contents

Overview

Active ingredient
Ketotifen Fumarate
Route
Ophthalmic
Label date
2026-05-15

Indications and usage

Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Purpose

Antihistamine

Dosage and administration

Directions

  • Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
  • Children under 3 years of age: Consult a doctor.

Warnings

For external use only 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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

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

Active ingredient (label)

Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)

Inactive ingredients

s benzalkonium chloride 0.01%, glycerol, water for injection, sodium hydroxide and/or hydrochloric acid.

Keep out of reach of children

of children. If swallowed, get medical help or contact a Poison Control Center right away.