{"active_ingredient":["Active ingredient Ketotifen 0.025%"],"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":"20240516","id":"38519d56-77cc-43cc-9b74-6ef2fc796a0d","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":["Safeway"],"package_ndc":["21130-601-05"],"product_ndc":["21130-601"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["311237"],"spl_id":["38519d56-77cc-43cc-9b74-6ef2fc796a0d"],"spl_set_id":["5fccbb63-7859-484c-b7b3-9de711364c09"],"substance_name":["KETOTIFEN FUMARATE"],"unii":["HBD503WORO"]},"other_safety_information":["Other information store at 4-25 °C (39-77 °F)"],"package_label_principal_display_panel":["Package/Label Principal Display Panel – 5mL carton Compare to Systane ZADITOR active ingredient* NDC 21130-601-05 Signature SELECT® 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 STERILE 0.17 FL OZ (5 mL) 20074700 GI60107 carton"],"purpose":["Purpose Antihistamine (equivalent to ketotifen fumarate 0.035%)"],"questions":["Questions? {Phone icon} Call: 1-800-459-7043 *This product is not manufactured or distributed by Alcon owner of the trademarks Systane and ZADITOR."],"set_id":"5fccbb63-7859-484c-b7b3-9de711364c09","spl_product_data_elements":["Eye Itch Relief Ketotifen Fumarate BENZALKONIUM CHLORIDE GLYCERIN HYDROCHLORIC ACID SODIUM HYDROXIDE WATER KETOTIFEN FUMARATE KETOTIFEN"],"stop_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"],"version":"5","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"]}