ZADITOR ANTIHISTAMINE EYE DROPS- ketotifen fumarate solution/ drops 
Novartis Pharmaceuticals Corporation

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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.

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.
  • Store between 4°-25°C (39°-77°F).

Inactive ingredients

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

Questions?

call toll-free

1-866-393-6336, weekdays,

8:30 AM - 5:00 PM EST.

Serious side effects associated with the use of this product may be reported to this number.

PRINCIPAL DISPLAY PANEL

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

ZADITOR

ketotifen fumarate ophthalmic solution

Antihistamine Eye Drops

Original Prescription Strength

Up to 12 Hour Itch Relief

30 Day Supply

Works in Minutes

For Ages 3 Years and Older

Do not use if seal on bottle is missing or broken.

Zaditor 5mL Carton

ZADITOR  ANTIHISTAMINE EYE DROPS
ketotifen fumarate solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0078-0476
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0078-0476-41 2 in 1 CARTON 09/22/2009 12/21/2012
1 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2 NDC:0078-0476-61 1 in 1 CARTON 09/22/2009 12/21/2012
2 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021066 09/22/2009 12/21/2012
Labeler - Novartis Pharmaceuticals Corporation (002147023)

Revised: 9/2009
Novartis Pharmaceuticals Corporation