Zyrtec Itchy Eye

ketotifen fumarate

Dosage Form: eye drops
ZYRTEC®

ITCHY EYE

DROPS

Drug Facts

Active ingredient

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

Purpose

Antihistamine

Use

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

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 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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• 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.


• do not use if outer package is torn or opened


• Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].

Inactive ingredients

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

Questions or comments?

call 1-800-343-7805

PRINCIPAL DISPLAY PANEL

NDC 50580-732-05

ZYRTEC®

NEW!

ITCHY EYE

DROPS

ketotifen fumarate ophthalmic solution

ANTIHISTAMINE EYE DROPS

ORIGINAL

PRESCRIPTION

STRENGTH

UP TO

12 HOURS

ALLERGY

ITCHY EYE

RELIEF

WORKS IN MINUTES

For Ages 3 Yrs. & Older

30 Day Supply

0.17 FL OZ (5 mL)

STERILE

ZYRTEC   ITCHY EYE ketotifen fumarate  solution/ drops

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 50580-732 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ketotifen fumarate (Ketotifen) Ketotifen fumarate 0.345 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50580-732-05 1 BOTTLE In 1 PACKAGE contains a BOTTLE, PLASTIC 1 5 mL In 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (50580-732-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077354	07/01/2009

Labeler - McNeil Consumer Healthcare Division of McNeil-PPC, Inc. (878046358)

Revised: 02/2010McNeil Consumer Healthcare Division of McNeil-PPC, Inc.

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