ZYRTEC  ITCHY EYE- ketotifen fumarate solution/ drops 
McNeil Consumer Healthcare Division of McNeil-PPC, Inc.

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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

Principal Display Panel
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) Ketotifen0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride 
glycerin 
sodium hydroxide 
hydrochloric acid 
water 
Packaging
#Item CodePackage Description
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
ANDAANDA07735407/01/200911/30/2011
Labeler - McNeil Consumer Healthcare Division of McNeil-PPC, Inc. (878046358)

Revised: 08/2013
Document Id: 9e283391-6fdc-4e5a-9bac-9c27a7e43483
Set id: 7ca8b8df-6910-4a78-82a6-c5217ac5a9ae
Version: 2
Effective Time: 20130814
 
McNeil Consumer Healthcare Division of McNeil-PPC, Inc.