Active Ingredient
Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)
Ketotifen Fumarate Solution/ Drops
FDA Label NDC 0536-1252
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Ketotifen Fumarate (NDC 0536-1252). 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, when using this product, stop use and ask doctor if you experience any of the following:, keep out of reach of children., directions, 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
When Using This Product
▪ 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
Stop Use And Ask Doctor If You Experience Any Of The Following:
▪ eye pain▪ changes in vision▪ redness of the eyes▪ itching that worsens or lasts more than 72 hours
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?
Toll Free Product Information
Call: 1-800-645-2158
Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive
Suite 233, Livonia, MI 48152
www.rugbylaboratories.com
Product of Italy
Package/Label Principal Display Panel
Carton5ml (Image 01)
NDC 0536-1252-40
Rugby®
Compare to the
active ingredient
in Zaditor*
Eye Itch Relief
ketotifen fumarate ophthalmic solution, 0.035%
ANTIHISTAMINE EYE DROPS
UP TO
12
HOURS
EYE ITCH RELIEF
▪ Works in Minutes▪ Original Prescription
Strength▪ For Ages 3 Years
and Older
5mL
STERILE (0.17 FL OZ)
* Please review the disclaimer below.
