{"active_ingredient":["Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)"],"do_not_use":["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"],"dosage_and_administration":["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. Children under 3 years of age: consult a doctor"],"effective_time":"20231009","id":"074cd409-1adb-31c0-e063-6394a90a13a8","inactive_ingredient":["benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection"],"indications_and_usage":["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. Children under 3 years of age: consult a doctor"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{},"package_label_principal_display_panel":["72189-461-05"],"purpose":["Antihistamine"],"questions":["Toll Free Product Information Call: 1-800-645-2158 Distributed by: RUGBY® LABORATORIES 17177 N Laurel Park Drive Suite 233, Livonia, MI 48152 www.rugbylaboratories.com Product of Italy"],"set_id":"f8993d29-37ae-6297-e053-6394a90a8940","spl_product_data_elements":["Ketotifen Fumarate Ketotifen Fumarate KETOTIFEN FUMARATE KETOTIFEN SODIUM HYDROXIDE BENZALKONIUM CHLORIDE WATER GLYCERIN HYDROCHLORIC ACID"],"stop_use":["Stop use and ask doctor if you experience any of the following: ▪ eye pain ▪ changes in vision ▪ redness of the eyes ▪ itching that worsens or lasts more than 72 hours"],"storage_and_handling":["Store at 4-25°C (39-77°F)"],"version":"4","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 doctor if you experience any of the following: ▪ eye pain ▪ changes in vision ▪ redness of the eyes ▪ itching that worsens or lasts more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.","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"]}