{"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":"20250912","id":"0c2e7ac9-3977-48ba-995c-004dba0d0ad5","inactive_ingredient":["Inactive ingredients Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH."],"indications_and_usage":["Uses 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":["Eye Itch Relief"],"generic_name":["KETOTIFEN FUMARATE"],"is_original_packager":[true],"manufacturer_name":["CARDINAL HEALTH 110, LLC. DBA LEADER"],"package_ndc":["70000-0124-1"],"product_ndc":["70000-0124"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["311237"],"spl_id":["0c2e7ac9-3977-48ba-995c-004dba0d0ad5"],"spl_set_id":["add414c5-b6c5-4bb5-8d8a-ddc507a27131"],"substance_name":["KETOTIFEN FUMARATE"],"unii":["HBD503WORO"],"upc":["0096295128901"]},"other_safety_information":["Other information ▪ only for use in the eye. ▪ store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]."],"package_label_principal_display_panel":["Principal Display Panel Text for Container Label: LEADER™ NDC 70000-0124-1 Sterile Eye Itch Relief Ketotifen Fumarate Ophthalmic Solution Antihistamine Eye Drops 5 mL (0.17FL OZ) Figure","Principal Display Panel Text for Carton Label: LEADER™ NDC 70000-0124-1 Sterile Eye Itch Relief Ketotifen Fumarate Ophthalmic Solution Antihistamine Eye Drops Up to 12 Hours of Itch Relief Works in Minutes Original Prescription Strength For Ages 3 Years & Older 30-day Supply COMPARE TO ZADITOR® ANTIHISTAMINE EYE DROPS Active ingredient* 100% Money Back Guarantee 5 mL (0.17 FL OZ) Figure"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-932-5676"],"set_id":"add414c5-b6c5-4bb5-8d8a-ddc507a27131","spl_product_data_elements":["Eye Itch Relief Ketotifen Fumarate KETOTIFEN FUMARATE KETOTIFEN BENZALKONIUM CHLORIDE GLYCERIN WATER HYDROCHLORIC ACID SODIUM HYDROXIDE"],"spl_unclassified_section":["Drug Facts",". *This product is not manufactured or distributed by Alcon Laboratories, distributor of Zaditor®. CardinalHealth™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 100% Money Back Guarantee Return to place of purchase. 2080 CIN 5266457 REV. 11/16 LKAAL Rev. 08/16 CIN 5266457 REV. 11/16 LKAAC Rev. 08/16"],"spl_unclassified_section_table":["
2080CIN 5266457 REV. 11/16LKAAL Rev. 08/16
CIN 5266457 REV. 11/16LKAAC Rev. 08/16
"],"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 more than 72 hours"],"version":"5","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 the tip of container to any surface to avoid contamination ▪ remove contact lenses before use ▪ wait at least 10 minutes before reinserting contact lens 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 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 the tip of container to any surface to avoid contamination ▪ remove contact lenses before use ▪ wait at least 10 minutes before reinserting contact lens after use ▪ replace cap after each use"]}