ZADITOR- ketotifen fumarate solution 
Alcon Laboratories, Inc.

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 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

Stop use and ask a doctor if you experience any of the following:

Keep out of reach of children. 
If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

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

Questions?

In the US, call toll-free 1-800-757-9195

alcon.medinfo@alcon.com

www.systane.com

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Systane®
ZADITOR®

ketotifen fumarate ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS
EYE ITCH RELIEF

up to 12 HOURS

Alcon

STERILE
30 DAY SUPPLY
5mL (0.17 FL OZ)

Systane®
ZADITOR®

Original Prescription Strength
Up to 12 Hour Itch Relief
Works in Minutes

For Ages 3 Years and Older

30 DAY SUPPLY

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.
Fort Worth, TX 76134 USA
Country of Origin: Italy

300048650-0821

ACTUAL SIZE

LOT:          EXP.:

Zaditor Carton

Systane®
ZADITOR®
ketotifen fumarate ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS
EYE ITCH RELIEF
5mL (0.17 FL OZ) STERILE

Only for use in the eye. Store between 4° - 25°C (39° - 77°F).

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.

Manufactured by:
Alcon Laboratories, Inc.
6201 South Freeway,
Fort Worth, TX 76134

H15433-1018

bottle label
ZADITOR 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-4011
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Hydrochloric Acid (UNII: QTT17582CB)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0065-4011-051 in 1 CARTON03/13/2013
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:0065-4011-062 in 1 CARTON01/08/2013
25 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC:0065-4011-113 in 1 CARTON02/13/2015
35 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07720001/08/2013
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Research LLC (007672236)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research LLC007672236manufacture(0065-4011)

Revised: 12/2023
Document Id: bed738a0-2943-46e7-a65e-2440dac7971b
Set id: ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f
Version: 13
Effective Time: 20231215
 
Alcon Laboratories, Inc.