Drug Facts

Composition & Product

Active Ingredients

Polyethylene Glycol 400 (4 mg) Propylene Glycol (3 mg)

Inactive Ingredients

Boric Acid Calcium Chloride Guar Gum Magnesium Chloride Polidronium Chloride Potassium Chloride Water Sodium Chloride Zinc Chloride Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2003-02-25 Until 2018-04-30

Medication Information

Description

Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant

Uses

For the temporary relief of burning and irritation due to dryness of the eye

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
continued redness or irritation of the eye
condition worsens or persists for more than 72 hours

Section 55105-1

Active Ingredients	Purpose
Polyethylene Glycol 400 0.4%	Lubricant
Propylene Glycol 0.3%	Lubricant

Warnings

For external use only

Directions

put 1 or 2 drops in the affected eye(s) as needed

Do Not Use

if this product changes color or becomes cloudy
if you are sensitive to any ingredient in this product

Questions?

In the U.S. call 1-800-757-9195

[email protected]

www.systane.com

Other Information

store at room temperature

Inactive Ingredients:

Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, polyquaternium-1 as a preservative, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

Systane ^®

LUBRICANT EYE DROPS

ORIGINAL

LONG-LASTING

DRY EYE RELIEF

Refreshes & Lubricates

Soothing Comfort

#1 DOCTOR RECOMMENDED BRAND¹

Alcon

STERILE

15 mL (1/2 FL OZ)

SIDE PANEL

TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

Enjoy lasting comfort with SYSTANE^® Lubricant Eye Drops.

SYSTANE^® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.

ACTUAL SIZE

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

¹Based on a survey of eye care professionals. Data on file.

www.alconpatents.com

Made in USA from domestic and imported materials

9016879-1118

LOT: EXP:

Systane^®

LUBRICANT EYE DROPS

ORIGINAL LONG-LASTING

DRY EYE RELIEF

Refreshes & Lubricates

Soothing Comfort

#1 DOCTOR RECOMMENDED BRAND ¹

Alcon

STERILE

15 mL (1/2 FL OZ)

SIDE PANEL

TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

Enjoy lasting comfort with SYSTANE® Lubricant Eye Drops.

SYSTANE^® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.

ACTUAL SIZE

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

¹Based on a survey of eye care professionals. Data on file.

www.alconpatents.com

Country of Origin: Singapore

SC00264-0219

LOT: EXP:

When Using This Product

do not touch tip of container to any surface to avoid contamination
replace cap after each use

Structured Label Content

Uses

For the temporary relief of burning and irritation due to dryness of the eye

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
continued redness or irritation of the eye
condition worsens or persists for more than 72 hours

Section 55105-1 (55105-1)

Active Ingredients	Purpose
Polyethylene Glycol 400 0.4%	Lubricant
Propylene Glycol 0.3%	Lubricant

Warnings

For external use only

Directions

put 1 or 2 drops in the affected eye(s) as needed

Do Not Use (Do not use)

if this product changes color or becomes cloudy
if you are sensitive to any ingredient in this product

Questions?

In the U.S. call 1-800-757-9195

[email protected]

www.systane.com

Other Information

store at room temperature

Inactive Ingredients:

Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, polyquaternium-1 as a preservative, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Systane ^®

LUBRICANT EYE DROPS

ORIGINAL

LONG-LASTING

DRY EYE RELIEF

Refreshes & Lubricates

Soothing Comfort

#1 DOCTOR RECOMMENDED BRAND¹

Alcon

STERILE

15 mL (1/2 FL OZ)

SIDE PANEL

TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

Enjoy lasting comfort with SYSTANE^® Lubricant Eye Drops.

SYSTANE^® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.

ACTUAL SIZE

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

¹Based on a survey of eye care professionals. Data on file.

www.alconpatents.com

Made in USA from domestic and imported materials

9016879-1118

LOT: EXP:

Systane^®

LUBRICANT EYE DROPS

ORIGINAL LONG-LASTING

DRY EYE RELIEF

Refreshes & Lubricates

Soothing Comfort

#1 DOCTOR RECOMMENDED BRAND ¹

Alcon

STERILE

15 mL (1/2 FL OZ)

SIDE PANEL

TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

Enjoy lasting comfort with SYSTANE® Lubricant Eye Drops.

SYSTANE^® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.

ACTUAL SIZE

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

¹Based on a survey of eye care professionals. Data on file.

www.alconpatents.com

Country of Origin: Singapore

SC00264-0219

LOT: EXP:

When Using This Product (When using this product)

do not touch tip of container to any surface to avoid contamination
replace cap after each use

Advanced Ingredient Data

[{"name": "Polyethylene Glycol 400", "unii": "B697894SGQ", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Boric Acid", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Calcium Chloride", "unii": "M4I0D6VV5M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Guar Gum", "unii": "E89I1637KE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Magnesium Chloride", "unii": "02F3473H9O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polidronium Chloride", "unii": "6716Z5YR3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Potassium Chloride", "unii": "660YQ98I10", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Chloride", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Zinc Chloride", "unii": "86Q357L16B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hydrochloric Acid", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Hydroxide", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of burning and irritation due to dryness of the eye", "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 continued redness or irritation of the eye condition worsens or persists for more than 72 hours", "55105-1": "Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant", "Warnings": "For external use only", "Directions": "put 1 or 2 drops in the affected eye(s) as needed", "Do not use": "if this product changes color or becomes cloudy if you are sensitive to any ingredient in this product", "Questions?": "In the U.S. call 1-800-757-9195 alcon.medinfo@alcon.com www.systane.com", "Other Information": "store at room temperature", "Inactive Ingredients:": "Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, polyquaternium-1 as a preservative, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.", "PRINCIPAL DISPLAY PANEL": "Systane ® LUBRICANT EYE DROPS ORIGINAL LONG-LASTING DRY EYE RELIEF Refreshes & Lubricates Soothing Comfort #1 DOCTOR RECOMMENDED BRAND 1 Alcon STERILE 15 mL (1/2 FL OZ) SIDE PANEL TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. Enjoy lasting comfort with SYSTANE ® Lubricant Eye Drops. SYSTANE ® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed. ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 1 Based on a survey of eye care professionals. Data on file. www.alconpatents.com Made in USA from domestic and imported materials 9016879-1118 LOT: EXP: Systane ® LUBRICANT EYE DROPS ORIGINAL LONG-LASTING DRY EYE RELIEF Refreshes & Lubricates Soothing Comfort #1 DOCTOR RECOMMENDED BRAND 1 Alcon STERILE 15 mL (1/2 FL OZ) SIDE PANEL TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. Enjoy lasting comfort with SYSTANE® Lubricant Eye Drops. SYSTANE ® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed. ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 1 Based on a survey of eye care professionals. Data on file. www.alconpatents.com Country of Origin: Singapore SC00264-0219 LOT: EXP:", "When using this product": "do not touch tip of container to any surface to avoid contamination replace cap after each use"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information