Active Ingredient
Ketotifen 0.025%
(equivalent to ketotifen fumarate 0.035%)
Eye Itch Relief Solution
FDA Label NDC 70000-0522
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Eye Itch Relief (NDC 70000-0522). 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, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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▪ 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▪ eye pain▪ changes in vision▪ redness of the eyes▪ itching that worsens or lasts for more than 72 hours
When using this product
Stop use and ask a doctor if you experience any of the following:
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?
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NDC 70000-0522-2
Sterile Eye Drops
Eye Itch
Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS
Up to 12 Hours
Works in Minutes
Original Prescription Strength
For Ages 3 Years and Older
COMPARE TO
ZADITOR®
active ingredient
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0.34 FL OZ (10 mL)
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