FDA Label for Eye Itch Relief
View Indications, Usage & Precautions
Eye Itch Relief Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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.
Other
Drug Facts
Active Ingredient
Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)
Purpose
Antihistamine
Uses
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 the tip of container to any surface to avoid contamination
- remove contact lenses before use
- wait at least 10 minutes before reinserting contact lens 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 more than 72 hours
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 to 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, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.
Questions Or Comments?
1-800-932-5676
Principal Display Panel Text For Container Label:
LEADER™ Logo
NDC 70000-0124-1
Sterile
Eye Itch
Relief
Ketotifen Fumarate Ophthalmic Solution
Antihistamine Eye Drops
5 mL (0.17FL OZ)
Principal Display Panel Text For Carton Label:
LEADER™ Logo
NDC 70000-0124-1
Sterile
Eye Itch
Relief
Ketotifen Fumarate Ophthalmic Solution
Antihistamine Eye Drops
Up to 12 Hours
of Itch Relief COMPARE TO
Works in Minutes ZADITOR®
Original Prescription ANTIHISTAMINE
Strength EYE DROPS
Active ingredient*
For Ages 3 Years
& Older 100% Money
30-day Supply Back Guarantee
5 mL (0.17 FL OZ)
* Please review the disclaimer below.