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Zyrtec Itchy Eye

Generic Name: ketotifen fumarate
Dosage Form: eye drops

ZYRTEC®
ITCHY EYE
DROPS

Drug Facts

Active ingredient

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

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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 Item Code (Source) NDC: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
Packaging
# Item Code Package Description
1 NDC:50580-732-05 1 BOTTLE, PLASTIC (BOTTLE) in 1 PACKAGE
1 5 mL in 1 BOTTLE, PLASTIC
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: 02/2010
 
McNeil Consumer Healthcare Division of McNeil-PPC, Inc.



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