FDA Label for Zaditor
View Indications, Usage & Precautions
Zaditor Product Label
The following document was submitted to the FDA by the labeler of this product Alcon Laboratories, Inc.. 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.
Otc - Purpose
| Active ingredient | Purpose |
| Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) | Antihistamine |
Indications & Usage
Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
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
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 between 4°-25°C (39°-77°F).
Inactive Ingredients
benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid
Questions?
In the US, call toll-free 1-800-757-9195
[email protected]
www.systane.com
Serious side effects associated with use of this product may be reported to this number.
Package Label.Principal Display Panel
Systane®
ZADITOR®
ketotifen fumarate ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS
EYE ITCH RELIEF
● Works in minutes
● Original prescription strength
● For ages 3 years and older
up to 12 HOURS
Alcon
STERILE
30 DAY SUPPLY
5mL (0.17 FL OZ)
Original Prescription Strength
Up to 12 Hour Itch Relief
Works in Minutes
For Ages 3 Years and Older
30 DAY SUPPLY
TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
a Novartis Division
Country of Origin: Italy
9016645-0918
ACTUAL SIZE
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