{"active_ingredient":["Active ingredient Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)"],"do_not_use":["Do not use if solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation"],"dosage_and_administration":["Directions Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor."],"effective_time":"20220617","id":"463cf8fa-9f84-62a4-8a27-ceea84ad6c88","inactive_ingredient":["Inactive ingredients benzalkonium chloride 0.01%, glycerol, hydrochloric acid and/or sodium hydroxide, and water for injection"],"indications_and_usage":["Use Temporarily relieves itchy eyes due to pollen, ragweed, 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":{},"package_label_principal_display_panel":["Principal Display Panel - Bottle Label McKesson - SunMark NDC 70677-0052-1 Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle","Principal Display Panel - Bottle Carton McKesson - SunMark NDC 70677-0052-1 Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? call us at 1-800-706-5575 (Monday to Friday 8:30 am – 5:00 pm Eastern Standard Time)"],"set_id":"9c67c2d6-3e03-6bc5-5431-03cd465eee37","spl_product_data_elements":["Ketotifen Fumarate Ketotifen Fumarate KETOTIFEN FUMARATE Ketotifen GLYCERIN SODIUM HYDROXIDE HYDROCHLORIC ACID BENZALKONIUM CHLORIDE 5mL-CTN-SNMK 5mL-LBL-SNMK"],"spl_unclassified_section":["Other information Only for use in the eye. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]."],"stop_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"],"version":"5","warnings":["Warnings For external use only Do not use if solution changes color or becomes cloudy 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."],"when_using":["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"]}