FDA Label for Ketotifen Fumarate
View Indications, Usage & Precautions
Ketotifen Fumarate Product Label
The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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.
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
Otc - Stop 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
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 Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).
Questions?
call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST
Package Label.Principal Display Panel
Principal Display Panel Text for Carton Label:
Now OTC! NDC 71205-115-05
Ketotifen
Fumarate
Ophthalmic
Solution
ANTIHISTAMINE EYE DROPS
UP TO 12 HOURS EYE ITCH RELIEF
Works in Minutes
Original Prescription Strength
FOR AGES 3 YEARS AND OLDER
30 DAY SUPPLY
5 mL (0.17 FL OZ) Sterile
* Please review the disclaimer below.