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Zyrtec Itchy Eye Prescribing Information

Package insert / product label
Generic name: ketotifen fumarate
Dosage form: eye drops
Drug class: Ophthalmic antihistamines and decongestants

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

The Zyrtec Itchy Eye Drops brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.

Drug Facts

Active ingredient

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

Purpose

Antihistamine

Indications and Usage for Zyrtec Itchy Eye

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)

Zyrtec Itchy Eye Dosage and Administration

  • 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.

Storage and Handling

  • 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

Principal Display Panel
ZYRTEC ITCHY EYE
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-732
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen fumarate0.345 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-732-051 in 1 PACKAGE
15 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07735407/01/2009
Labeler - McNeil Consumer Healthcare Division of McNeil-PPC, Inc. (878046358)

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