Systane®

Drug Facts

Composition & Product

Active Ingredients

Propylene Glycol (0.06 mg)

Inactive Ingredients

Boric Acid Dimyristoylphosphatidylglycerol, Dl- Edetate Disodium Guar Gum Mineral Oil Polyoxyl 40 Stearate Sorbitan Tristearate Sorbitol Water Hydrochloric Acid Sodium Hydroxide Polidronium Chloride

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-06-25

Medication Information

Description

Active Ingredient Purpose Propylene Glycol 0.6% Lubricant

Uses

for the temporary relief of burning and irritation due to dryness of the eye
for use as a lubricant to prevent further irritation or to relive 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 Ingredient	Purpose
Propylene Glycol 0.6%	Lubricant

Warnings

For external use only

Directions

shake well before using
put 1 or 2 drops in the affected eye(s) as needed

Do Not Use

if this product changes color
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, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD^® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

Systane^®

LUBRICANT EYE DROPS

BALANCE

Restoring

Dry Eye Relief

Locks in moisture

Tear evaporation protection

Clinically proven

DOCTOR RECOMMENDED #1 BRAND¹

Alcon

STERILE

10 mL (1/3 FL OZ)

LOT: EXP.:

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.

www.alconpatents.com

Made in USA from domestic and

imported materials

Systane ^®

BALANCE

Lubricant

Eye

Drops

restores the

natural tear’s

lipid layer to

lock in moisture

and protect

against tear

evaporation.

ACTUAL SIZE

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

¹ Based on a survey of eye care

professionals. Data on file.

300048644-0521

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
for use as a lubricant to prevent further irritation or to relive 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 Ingredient	Purpose
Propylene Glycol 0.6%	Lubricant

Warnings

For external use only

Directions

shake well before using
put 1 or 2 drops in the affected eye(s) as needed

Do Not Use (Do not use)

if this product changes color
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 (Other information)

store at room temperature

Inactive Ingredients: (Inactive ingredients:)

boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD^® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Systane^®

LUBRICANT EYE DROPS

BALANCE

Restoring

Dry Eye Relief

Locks in moisture

Tear evaporation protection

Clinically proven

DOCTOR RECOMMENDED #1 BRAND¹

Alcon

STERILE

10 mL (1/3 FL OZ)

LOT: EXP.:

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.

www.alconpatents.com

Made in USA from domestic and

imported materials

Systane ^®

BALANCE

Lubricant

Eye

Drops

restores the

natural tear’s

lipid layer to

lock in moisture

and protect

against tear

evaporation.

ACTUAL SIZE

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

¹ Based on a survey of eye care

professionals. Data on file.

300048644-0521

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": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": "0.06", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Boric Acid", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Dimyristoylphosphatidylglycerol, Dl-", "unii": "BI71WT9P3R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Edetate Disodium", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Guar Gum", "unii": "E89I1637KE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Mineral Oil", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polyoxyl 40 Stearate", "unii": "13A4J4NH9I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sorbitan Tristearate", "unii": "6LUM696811", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sorbitol", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "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": ""}, {"name": "Polidronium Chloride", "unii": "6716Z5YR3G", "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 for use as a lubricant to prevent further irritation or to relive 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 Ingredient Purpose Propylene Glycol 0.6% Lubricant", "Warnings": "For external use only", "Directions": "shake well before using put 1 or 2 drops in the affected eye(s) as needed", "Do not use": "if this product changes color 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, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD ® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.", "PRINCIPAL DISPLAY PANEL": "Systane ® LUBRICANT EYE DROPS BALANCE Restoring Dry Eye Relief Locks in moisture Tear evaporation protection Clinically proven DOCTOR RECOMMENDED #1 BRAND 1 Alcon STERILE 10 mL (1/3 FL OZ) LOT: EXP.: 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. www.alconpatents.com Made in USA from domestic and imported materials Systane ® BALANCE Lubricant Eye Drops restores the natural tear’s lipid layer to lock in moisture and protect against tear evaporation. ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 1 Based on a survey of eye care professionals. Data on file. 300048644-0521 ", "When using this product": "do not touch tip of container to any surface to avoid contamination replace cap after each use"}