Zaditor
Ketotifen fumarate · Solution · Ophthalmic
Active ingredient
Active ingredient Purpose Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Antihistamine
Purpose
Active ingredient Purpose Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Antihistamine
Uses
Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Warnings
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
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
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
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
Inactive ingredients
Inactive ingredients benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid
Questions?
Questions? In the US, call toll-free 1-800-757-919 5 alcon.medinfo@alcon.com www.systane.com Serious side effects associated with use of this product may be reported to this number.
Label text from the FDA structured product label by Alcon Laboratories, Inc. (revised Dec 15, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ketotifen Fumarate in 1 product
Zaditor NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0065-4011 | Ketotifen Fumarate .25 mg/mL Solution | Alcon Laboratories, Inc. | ANDA |
Zaditor recalls
- D-1317-2022 Aug 17, 2022 · Class II · Terminated
CGMP Deviations: products were stored outside the drug label specifications.
Frequently asked questions
What is Zaditor used for?
Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Who makes Zaditor?
Zaditor is listed by 1 labeler in the FDA NDC directory, including Alcon Laboratories, Inc..
Has Zaditor been recalled?
The FDA enforcement database lists 1 recall for Zaditor, most recently D-1317-2022 (class ii): CGMP Deviations: products were stored outside the drug label specifications.