{"active_ingredient":["Active ingredient Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)"],"dosage_and_administration":["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 ▪ if using other ophthalmic products while using this product, wait at least 5 minutes between each product ▪ Children under 3 years of age: consult a doctor"],"effective_time":"20231208","id":"5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623","inactive_ingredient":["Inactive ingredients benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection"],"indications_and_usage":["Uses For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander."],"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."],"openfda":{"application_number":["NDA021996"],"brand_name":["Eye Itch Relief"],"generic_name":["KETOTIFEN FUMARATE"],"is_original_packager":[true],"manufacturer_name":["Cardinal Health"],"package_ndc":["70000-0522-1","70000-0522-2"],"product_ndc":["70000-0522"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["311237"],"spl_id":["5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623"],"spl_set_id":["e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8"],"substance_name":["KETOTIFEN FUMARATE"],"unii":["HBD503WORO"],"upc":["0096295138887"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel LEADER[heart icon]™ NDC 70000-0522-2 Sterile / Eye Drops Eye Itch Relief ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS Up to 12 Hours Works in Minutes Original Prescription Strength For Ages 3 Years and Older COMPARE to Systane ZADITOR active ingredient* 100% Money Back Guarantee 0.34 FL OZ (10 mL) 9688902 F860109 carton"],"purpose":["Purpose Antihistamine"],"set_id":"e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8","spl_product_data_elements":["Eye Itch Relief ketotifen fumarate KETOTIFEN FUMARATE KETOTIFEN BENZALKONIUM CHLORIDE GLYCERIN HYDROCHLORIC ACID SODIUM HYDROXIDE WATER"],"spl_unclassified_section":["Other information Store at 4-25 °C (39-77 °F)","Questions or comments? [phone icon]Call: 1-877-758-1480"],"version":"3","warnings":["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 a doctor if you experience any of the following: • eye pain • changes in vision • redness of the eyes • itching that worsens or lasts for more than 72 hours"]}