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FDA LABEL GENERIC: Ketotifen MFR: A-S Medication Solutions

Zaditor 0.025 % (ketotifen Fumarate 0.035 % ) Ophthalmic Solution

Table of Contents

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

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 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

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

OTHER INFORMATION

Only for use in the eye. Store between 4°-25°C (39°-77°F).

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid

HOW SUPPLIED

Product: 50090-1037

NDC: 50090-1037-0 5 mL in a BOTTLE, DROPPER

QUESTIONS?

call toll-free
1-800-757-9195
[email protected]
www.zaditor.com
Serious side effects associated with use of this product may be reported to this number.

ketotifen fumarate