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 Cvs Pharmacy. 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.
Active Ingredient
Ketotifen 0.025%
(equivalent to ketotifen fumarate 0.035%)
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 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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Package/Label Principal Display Panel
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Health
NDC 69842-275-10
Eye Itch
Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS
• Works in minutes• Original prescription strength• For ages 3 years & older• 60-day supply
UP TO
12
HOURS
EYE ITCH
RELIEF
Package Contains
One Bottle
STERILE
0.034 FL OZ (10 mL)
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