Ketotifen Fumarate Ophthalmic Solution Solution/ Drops
FDA Label NDC 70244-041

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sentiss Pharmaceuticals Llc for the product Ketotifen Fumarate Ophthalmic Solution (NDC 70244-041). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

Otc - Keep Out Of Reach Of Children

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

Packaging

Ketolbl3 (70244 041.jpg)

Ketolbl3 (70244 041.jpg)

* Please review the disclaimer below.