Active Ingredient
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)
Good Neighbor Pharmacy Eye Itch Relief
FDA Label NDC 68258-8900
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dispensing Solutions, Inc. for the product Good Neighbor Pharmacy Eye Itch Relief (NDC 68258-8900). 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, do not use, when using this product, stop use and ask a doctor if, 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
Use
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Do Not Use
. If solution changes color or becomes cloudyi
. 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
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 for more than 72 hours
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 8-12 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 20-25°C (68-77°F) [see USP Controlled Room Temperature]
Inactive Ingredients
benzalkonium chloride 0.01%, glycerin, purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).
Questions Or Comments?
1-800-719-9260
Package Label Principal Display Panel
NDC 68258-8900-05
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