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 15, 2023
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- Warnings
- When using this product
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
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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
Country of Origin: Italy
300048650-0821
ACTUAL SIZE
LOT: EXP.:
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 -
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 03/13/2013 1 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:0065-4011-06 2 in 1 CARTON 01/08/2013 2 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 3 NDC:0065-4011-11 3 in 1 CARTON 02/13/2015 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 01/08/2013 Labeler - Alcon Laboratories, Inc. (008018525) Registrant - Alcon Research LLC (007672236) Establishment Name Address ID/FEI Business Operations Alcon Research LLC 007672236 manufacture(0065-4011)