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Drug Facts
Itchy Eye
FDA Label NDC 41250-303
14 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 Itchy Eye (NDC 41250-303). 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 other, active ingredient, purpose, use, warnings, do not use, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)
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 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
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 41250-303-01
Meijer™ Logo
Itchy Eye Drops
Ketotifen Fumarate Ophthalmic Solution 0.035%
Antihistamine
Eye Drops
10 mL
0.34 FL OZ
STERILE
Principal Display Panel Text For Container Label (Mei02 0005 01)
Principal Display Panel Text for Carton Label:
NDC 41250-303-01 Compare to Alaway®
active ingredient*
Meijer™ Logo
UP TO 12
HOURS OF RELIEF
Itchy Eye Drops
Ketotifen Fumarate Ophthalmic Solution 0.035%
Antihistamine Eye Drops
Works in Minutes
Original Prescription Strength
For ages 3 years and older
60-day supply
10 mL 0.34 FL OZ STERILE
Principal Display Panel Text For Carton Label (Mei02 0005 02)
* Please review the disclaimer below.
