{"active_ingredient":["OTC - ACTIVE INGREDIENT SECTION Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)"],"dosage_and_administration":["DOSAGE & ADMINISTRATION SECTION 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":"20171109","how_supplied":["HOW SUPPLIED Product: 50090-1037 NDC: 50090-1037-0 5 mL in a BOTTLE, DROPPER"],"id":"06e5bdc8-93d0-4ffd-9349-d0f54cbc8fb3","inactive_ingredient":["INACTIVE INGREDIENT SECTION benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid"],"indications_and_usage":["INDICATIONS & USAGE SECTION Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander."],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN SECTION If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"other_safety_information":["OTHER INFORMATION Only for use in the eye. Store between 4°-25°C (39°-77°F)."],"package_label_principal_display_panel":["ketotifen fumarate Label Image"],"purpose":["OTC - PURPOSE SECTION Antihistamine"],"questions":["QUESTIONS? call toll-free 1-800-757-9195 MedInfo@AlconLabs.com www.zaditor.com Serious side effects associated with use of this product may be reported to this number."],"set_id":"7a00b07f-3bc6-47be-8063-b2b076c69191","spl_product_data_elements":["Zaditor ketotifen fumarate KETOTIFEN FUMARATE KETOTIFEN Benzalkonium Chloride Glycerin Sodium Hydroxide Hydrochloric Acid Water"],"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 SECTION 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":["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"]}