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

up to 12 HOURS

Alcon

STERILE
30 DAY SUPPLY
5mL (0.17 FL OZ)

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
a Novartis Division
Country of Origin: Italy

9016645-0918

ACTUAL SIZE

LOT:          EXP.:

Carton2
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 CARTON12/21/2012
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:0065-4011-062 in 1 CARTON12/21/2012
25 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC:0065-4011-113 in 1 CARTON12/21/2012
35 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07720012/21/2012
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Research LLC (007672236)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research LLC007672236manufacture(0065-4011)

Revised: 10/2020
Document Id: de867745-a74e-4381-9d30-85421fab620b
Set id: ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f
Version: 9
Effective Time: 20201016
 
Alcon Laboratories, Inc.