{"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":"6ca0ed6a-4b37-44b1-97d1-7855ab238077","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":["TOPCO ASSOCIATES LLC"],"package_ndc":["36800-097-05"],"product_ndc":["36800-097"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["311237"],"spl_id":["6ca0ed6a-4b37-44b1-97d1-7855ab238077"],"spl_set_id":["b723daa3-6c6f-4a96-a15d-0d5866f28ca4"],"substance_name":["KETOTIFEN FUMARATE"],"unii":["HBD503WORO"],"upc":["0036800489714"]},"other_safety_information":["Other information store at 4-25 °C (39-77 °F)"],"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC 36800-097-05 +Top Care ™ health COMPARE TO Systane ZADITOR active ingredient* Eye Itch Relief ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS UPTO 12 HOURS • Works in Minutes • Original Prescription Strength • For Ages 3 Years and Older STERILE 0.17FL OZ (5 mL) 9756901 FT60107 carton"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? [phone icon]Call: 1-888-423-0139"],"set_id":"b723daa3-6c6f-4a96-a15d-0d5866f28ca4","spl_product_data_elements":["Eye Itch Relief ketotifen fumarate KETOTIFEN FUMARATE KETOTIFEN BENZALKONIUM CHLORIDE GLYCERIN HYDROCHLORIC ACID SODIUM HYDROXIDE WATER"],"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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}