{"active_ingredient":["Active ingredient Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)"],"dosage_and_administration":["Directions Adults and children 3 years or 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 Other information Store at 4-25°C (39-77°F)"],"effective_time":"20210323","id":"23a94887-f625-4a01-bcda-131ca5286372","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 (1-800-222-1222) right away."],"openfda":{"application_number":["NDA021996"],"brand_name":["Equate Eye Itch Relief"],"generic_name":["KETOTIFEN FUMARATE"],"is_original_packager":[true],"manufacturer_name":["Wal-Mart Stores, Inc."],"package_ndc":["49035-231-10","49035-231-11"],"product_ndc":["49035-231"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["311237"],"spl_id":["23a94887-f625-4a01-bcda-131ca5286372"],"spl_set_id":["accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9"],"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 NDC 49035-231-11 equate ™ Eye Itch Relief ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS • Works in minutes • Original prescription strength • For ages 3 years and older • STERILE UP TO 12 HOURS 2 x 10 mL BOTTLES (0.34 FL OZ EACH) carton"],"purpose":["Purpose Antihistamine"],"set_id":"accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9","spl_product_data_elements":["Equate 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"]}