DOSAGE & ADMINISTRATION SECTION.

Directions. Adults and children years and older: put drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. Children under years of age: consult doctor.

INACTIVE INGREDIENT SECTION.

Inactive ingredients. benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection.

INDICATIONS & USAGE SECTION.

Uses. For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredient. Ketotifen 0.025%(equivalent to ketotifen fumerate 0.035%).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

OTC - PURPOSE SECTION.

Purpose. Antihistamine.

OTC - QUESTIONS SECTION.

Questions or comments. Toll Free Product InformationCall: 1-800-645-2158Distributed by: RUGBY(R) LABORATORIES 17177 Laurel Park DriveSuite 233, Livonia, MI 48152www.rugbylaboratories.comProduct of Italy.

OTC - STOP USE SECTION.

Stop use and ask doctor if you experience any of the following: eye painchanges in visionredness of the eyesitching that worsens or lasts more than 72 hours. eye pain. changes in vision. redness of the eyes. itching that worsens or lasts more than 72 hours.

OTC - WHEN USING SECTION.

When using this product remove contact lenses before usewait at least 10 minutes before re-inserting contact lenses after usedo not touch tip of container to any surface to avoid contaminationreplace cap after each use. 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package/Label Principal Display Panel. NDC 0536-1252-40 Rugby(R)Compare to theactive ingredientin ZaditorEye Itch Reliefketotifen fumarate ophthalmic solution, 0.035%ANTIHISTAMINE EYE DROPSUP TO12HOURS EYE ITCH RELIEF Works in MinutesOriginal PrescriptionStrength For Ages Yearsand Older 5mLSTERILE (0.17 FL OZ). Works in Minutes. Original PrescriptionStrength For Ages Yearsand Older. carton5ml.

SPL UNCLASSIFIED SECTION.

Other Information. Store at 4-25C (39-77F).

WARNINGS SECTION.

Warnings. For external use onlyDo not useif you are sensitive to any ingredient in this product if solution changes color or becomes cloudyto treat contact lens related irritation 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 usewait at least 10 minutes before re-inserting contact lenses after usedo not touch tip of container to any surface to avoid contaminationreplace cap after each use. 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 doctor if you experience any of the following: eye painchanges in visionredness of the eyesitching that worsens or lasts more than 72 hours. eye pain. changes in vision. redness of the eyes. itching that worsens or lasts more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.