{"active_ingredient":["Active ingredient Ketotifen 0.025% (equivalent to ketotifen fumerate 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":"20240722","id":"1ddd5a87-3863-532b-e063-6394a90ab8bf","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 Releif"],"generic_name":["KETOTIFEN FUMARATE"],"is_original_packager":[true],"manufacturer_name":["Rite Aid Corporation"],"package_ndc":["11822-5533-1"],"product_ndc":["11822-5533"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["311237"],"spl_id":["1ddd5a87-3863-532b-e063-6394a90ab8bf"],"spl_set_id":["6a7be1e9-27ff-44d8-85ed-fc1b0017180e"],"substance_name":["KETOTIFEN FUMARATE"],"unii":["HBD503WORO"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC 11822-5533-1 Compare to the active ingredient in Systane Zaditor * 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 0.34 FL OZ (10 mL) 9764201 LR60109 carton"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? [phone icon] Call: 1-866-767-8975"],"set_id":"6a7be1e9-27ff-44d8-85ed-fc1b0017180e","spl_product_data_elements":["Eye Itch Releif Ketotifen Fumarate BENZALKONIUM CHLORIDE GLYCERIN HYDROCHLORIC ACID SODIUM HYDROXIDE WATER KETOTIFEN FUMARATE KETOTIFEN"],"spl_unclassified_section":["Other information store at 4-25 °C (39-77 °F)"],"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":"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."],"when_using":["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"]}