Zaditor KETOTIFEN FUMARATE ALCON LABORATORIES, INC. FDA Approved Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
FunFoxMeds bottle
Substance Ketotifen Fumarate
Route
OPHTHALMIC
Applications
ANDA077200

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Purpose Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Antihistamine
Inactive Ingredients
Inactive ingredients benzalkonium chloride 0.01% glycerol purified water sodium hydroxide and/or hydrochloric acid
Quantities
5 ml
Treats Conditions
Use Temporarily Relieves Itchy Eyes Due To Pollen Ragweed Grass Animal Hair And Dander

Identifiers & Packaging

Container Type BOTTLE
UPC
0300654011057
UNII
HBD503WORO
Packaging

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

Package Descriptions
  • 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

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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
Purpose

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

When Using

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 & Ask a Doctor

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

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

Questions

Questions? In the US, call toll-free 1-800-757-919 5 [email protected] www.systane.com Serious side effects associated with use of this product may be reported to this number.


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