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ZADITOR by Alcon Laboratories, Inc.

Dosage form: solution
Ingredients: Ketotifen Fumarate .35mg in 1mL
Labeler: Alcon Laboratories, Inc.
NDC Code: 0065-0333

ZADITOR®
ANTIHISTAMINE EYE DROPS

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION
  • 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 INGREDIENT SECTION

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 use of this product may be reported to this number.

PRINCIPAL DISPLAY PANEL

NDC 0065-0333-05
STERILE

ZADITOR®
ketotifen fumarate ophthalmic solution
ANTIHISTAMINE EYE DROPS

up to 12 hours
EYE ITCH RELIEF

● Works in Minutes
● Original Prescription Strength

for ages 3 years and older
30 day supply

5 mL (0.17 FL OZ)

Alcon®

ZADITOR  
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0333
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketotifen Fumarate (Ketotifen) Ketotifen Fumarate.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride 
Glycerin 
Sodium Hydroxide 
Hydrochloric Acid 
Water 
Packaging
#Item CodePackage Description
1NDC:0065-0333-051 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02106609/22/2009
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIOperations
CIBA Vision Canada, Inc.247191463MANUFACTURE

Revised: 03/2012
 
Alcon Laboratories, Inc.

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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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