Ketotifen Fumarate Solution/ Drops
FDA Label NDC 50090-6472

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Ketotifen Fumarate (NDC 50090-6472). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask doctor if you experience any of the following:, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 Doctor If You Experience Any Of The Following:

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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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.

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?

Toll Free Product Information
Call: 1-800-645-2158

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive
Suite 233, Livonia, MI 48152
www.rugbylaboratories.com
Product of Italy

How Supplied

Product: 50090-6472

NDC: 50090-6472-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON

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