Zyrtec Itchy Eye

Dosage form: solution/ drops
Ingredients: Ketotifen fumarate 0.345mg in 1mL
Labeler: McNeil Consumer Healthcare Division of McNeil-PPC, Inc.
NDC Code: 50580-732

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-732
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketotifen fumarate (Ketotifen) Ketotifen fumarate0.345 mg  in 1 mL
Packaging
#Item CodePackage Description
1NDC:50580-732-051 BOTTLE, PLASTIC (BOTTLE) 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)

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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