drug Facts

Composition & Product

Active Ingredients

Ketotifen (.25 mg)

Inactive Ingredients

Benzalkonium Chloride Glycerin Sodium Hydroxide Hydrochloric Acid Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2013-01-08

Medication Information

Indications and Usage

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

Description

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

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 55105-1

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

Warnings

For external use only

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

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

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.

Other Information

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

Inactive Ingredients

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

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

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

Structured Label Content

Indications and Usage (34067-9)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 55105-1 (55105-1)

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

Warnings

For external use only

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

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

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.

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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

Package Label.principal Display Panel (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

Advanced Ingredient Data

[{"name": "Ketotifen", "unii": "X49220T18G", "classCode": "ACTIM", "strengthNumerator": ".25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Benzalkonium Chloride", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Hydroxide", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hydrochloric Acid", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "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", "55105-1": "Active ingredient Purpose Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Antihistamine", "Warnings": "For external use only", "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", "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", "Questions?": "In the US, call toll-free 1-800-757-919 5 alcon.medinfo@alcon.com www.systane.com Serious side effects associated with use of this product may be reported to this number.", "Other information": "Only for use in the eye. Store between 4°-25°C (39°-77°F).", "Inactive ingredients": "benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid", "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", "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"}