{"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 8-12 hours, no more than twice per day. • Children under 3 years of age: Consult a doctor."],"effective_time":"20191001","id":"78139082-90f2-4200-bf95-8a46315597ed","inactive_ingredient":["Inactive ingredients Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH)."],"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":{"application_number":["ANDA077958"],"brand_name":["Ketotifen Fumarate"],"generic_name":["KETOTIFEN FUMARATE"],"manufacturer_name":["Proficient Rx LP"],"original_packager_product_ndc":["17478-717"],"package_ndc":["71205-115-05"],"product_ndc":["71205-115"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["311237"],"spl_id":["78139082-90f2-4200-bf95-8a46315597ed"],"spl_set_id":["3a9e70ab-d188-488c-8c47-a2184eb4ef2c"],"substance_name":["KETOTIFEN FUMARATE"],"unii":["HBD503WORO"]},"package_label_principal_display_panel":["Principal Display Panel Text for Carton Label: Now OTC! NDC 71205-115-05 Ketotifen Fumarate Ophthalmic Solution ANTIHISTAMINE EYE DROPS UP TO 12 HOURS EYE ITCH RELIEF Works in Minutes Original Prescription Strength FOR AGES 3 YEARS AND OLDER 30 DAY SUPPLY 5 mL (0.17 FL OZ) Sterile 71205-115-05"],"purpose":["Purpose Antihistamine"],"questions":["Questions? call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST"],"set_id":"3a9e70ab-d188-488c-8c47-a2184eb4ef2c","spl_product_data_elements":["Ketotifen Fumarate Ketotifen Fumarate ketotifen fumarate Ketotifen benzalkonium chloride glycerin water hydrochloric acid sodium hydroxide"],"spl_unclassified_section":["Drug Facts","Other information • Only for use in the eye. • Store at 20° to 25°C (68° 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":"3","warnings":["Warnings 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"]}