Label: ZADITOR- ketotifen fumarate solution
- NDC Code(s): 0065-4011-05, 0065-4011-06, 0065-4011-11
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 9, 2021
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- ACTIVE INGREDIENT
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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)
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
a Novartis Division
Country of Origin: Italy
9016645-0918
ACTUAL SIZE
LOT: EXP.: -
INGREDIENTS AND APPEARANCE
ZADITOR
ketotifen fumarate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-4011 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen .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:0065-4011-05 1 in 1 CARTON 12/21/2012 1 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:0065-4011-06 2 in 1 CARTON 12/21/2012 2 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 3 NDC:0065-4011-11 3 in 1 CARTON 12/21/2012 3 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 ANDA ANDA077200 12/21/2012 Labeler - Alcon Laboratories, Inc. (008018525) Registrant - Alcon Research LLC (007672236) Establishment Name Address ID/FEI Business Operations Alcon Research LLC 007672236 manufacture(0065-4011)