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Zaditor by Alcon Laboratories, Inc.

Medically reviewed on March 8, 2018

Dosage form: solution
Ingredients: Ketotifen Fumarate .35mg in 1mL
Labeler: Alcon Laboratories, Inc.
NDC Code: 0065-4011

 Drug Facts 

Active ingredientPurpose
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)
Antihistamine

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

Warnings

For external use only

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, purified water, sodium hydroxide and/or hydrochloric acid

Questions?

call toll-free
1-800-757-9195
MedInfo@Alcon.com
www.zaditor.com

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Look   SAME FORMULA

Systane
®
ZADITOR

ketotifen fumarate ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

up to 12 HOURS EYE ITCH RELIEF

●   Works in minutes
●   Original prescription strength
●   For ages 3 years and older

5 mL (0.17 FL OZ)

STERILE

30 DAY SUPPLY

Alcon®

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134 USA
© 2009, 2012, 2016 Novartis

9013176-0416

ACTUAL SIZE

LOT:          EXP.:

ZADITOR  
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-4011
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketotifen Fumarate (Ketotifen) Ketotifen.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride 
Glycerin 
Sodium Hydroxide 
Hydrochloric Acid 
Water 
Packaging
#Item CodePackage Description
1NDC:0065-4011-051 BOTTLE, DROPPER in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
2NDC:0065-4011-062 BOTTLE, DROPPER in 1 CARTON
25 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07720012/21/2012
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Research Ltd (007672236)
Establishment
NameAddressID/FEIOperations
Alcon Research Ltd007672236manufacture(0065-4011)

 
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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