DOSAGE & ADMINISTRATION SECTION.

Directions. oadults and children years and older:oput drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per dayoif using other ophthalmic products while using this product, wait at least minutes between each product ochildren under years of age: consult doctor oadults and children years and older:oput drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per dayoif using other ophthalmic products while using this product, wait at least minutes between each product oput drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. oif using other ophthalmic products while using this product, wait at least minutes between each product ochildren 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 right away.

OTC - PURPOSE SECTION.

Purpose. Antihistamine.

OTC - QUESTIONS SECTION.

Questions or comments. Call: 1-800-553-5340.

OTC - STOP USE SECTION.

Stop use and ask doctor if you experience any of the following: oeye painochanges in visionoredness of the eyesoitching that worsens or lasts for more than 72 hours. oeye pain. ochanges in vision. oredness of the eyes. oitching that worsens or lasts for more than 72 hours.

OTC - WHEN USING SECTION.

When using this product oremove contact lenses before useowait at least 10 minutes before re-inserting contact lenses after useodo not touch tip of container to any surface to avoid contaminationoreplace cap after each use. oremove contact lenses before use. owait at least 10 minutes before re-inserting contact lenses after use. odo not touch tip of container to any surface to avoid contamination. oreplace cap after each use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package/Label Principal Display Panel. NEWLOOKNDC 24208-601-10 BAUSCH LOMBAlaway(R)ketotifen fumarateophthalmic solution 0.035%ANTIHISTAMINE EYE DROPSEye ItchRelief UP TO 12 HOURS Works in MinutesOriginalPrescription Strength For Ages3 Years And Older60DAY SUPPLYSTERILE 0.34 FL OZ (10 mL). carton.

SPL UNCLASSIFIED SECTION.

Other information. store at 4-25C (39-77F).

WARNINGS SECTION.

Warnings. For external use onlyDo not useoif you are sensitive to any ingredient in this product oif solution changes color or becomes cloudyoto treat contact lens related irritation oif you are sensitive to any ingredient in this product oif solution changes color or becomes cloudy. oto treat contact lens related irritation When using this product oremove contact lenses before useowait at least 10 minutes before re-inserting contact lenses after useodo not touch tip of container to any surface to avoid contaminationoreplace cap after each use. oremove contact lenses before use. owait at least 10 minutes before re-inserting contact lenses after use. odo not touch tip of container to any surface to avoid contamination. oreplace cap after each use. Stop use and ask doctor if you experience any of the following: oeye painochanges in visionoredness of the eyesoitching that worsens or lasts for more than 72 hours. oeye pain. ochanges in vision. oredness of the eyes. oitching that worsens or lasts for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.