Active Ingredient
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)
Eye Itch
FDA Label NDC 41250-302
13 label sections · Submitted to the FDA by Meijer Distribution Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Eye Itch (NDC 41250-302). 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, use, warnings, do not use, when using this product, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
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 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. (1-800-222-1222)
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.
Otc - Questions
Principal Display Panel Text For Container Label (Mei01 0007 01) Questions or comments? 
1-800-923-5676
Serious side effects associated with use of this product may be reported to this number
Package Label.Principal Display Panel
Principal Display Panel Text for Container Label:
NDC 41250-302-01
meijer logo®
eye itch relief
Ketotifen Fumarate
Ophthalmic Solution 0.035%
Antihistamine Eye Drops
5 mL (0.17 FL OZ)
Sterile
Principal Display Panel Text For Container Label (Mei01 0007 02)
Principal Display Panel Text for Carton Label:
NDC 41250-302-01
Compare to Zaditor®
active ingredient*
meijer Logo®
ORIGINAL
PRESCRIPTION
STRENGTH
eye itch
relief
Ketotifen Fumarate
Ophthalmic Solution 0.035%
Antihistamine Eye Drops
Up to 12 Hours of Relief
Works in Minutes
STERILE
30 Day Supply
5 mL (0.17 FL OZ)
Principal Display Panel Text For Carton Label (Mei01 0007 03)
* Please review the disclaimer below.
