Systane Gel Drops

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

Aminomethylpropanol Boric Acid Edetate Disodium Guaraprolose (3500 Mpa.s At 1%) Polidronium Chloride Potassium Chloride Sodium Chloride Sorbitol Water Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-02-09

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
for use as a protectant against further irritation or to relieve 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

shake well before using
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

aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD^® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

Systane ^®

LUBRICANT EYE GEL

GEL DROPS

SOOTHING DRY EYE RELIEF

Long-lasting formula

Day or night protection

#1 DOCTOR RECOMMENDED BRAND¹

LIQUID GEL

STERILE

10mL (1/3 FL OZ)

Alcon

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

Indulge your eyes in this easy-to-use droppable gel. Systane^® GEL DROPS forms a protective shield over your eyes to provide enduring relief day or night.

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

300048642-0621

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Systane^®

LUBRICANT EYE GEL

GEL DROPS

SOOTHING DRY EYE RELIEF

Long-lasting formula

Day or night protection

#1 DOCTOR RECOMMENDED BRANDS1

LIQUID GEL

STERILE

10mL (1/3 fl oz)

Alcon

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

Country of Origin: Singapore

Indulge your eyes in this easy-to-use droppable gel. Systane® GEL DROPS forms a protective shield over your eyes to provide enduring relief day or night.

ACTUAL SIZE

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

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

300072079-0525

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 protectant against further irritation or to relieve 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

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 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 (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD^® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Systane ^®

LUBRICANT EYE GEL

GEL DROPS

SOOTHING DRY EYE RELIEF

Long-lasting formula

Day or night protection

#1 DOCTOR RECOMMENDED BRAND¹

LIQUID GEL

STERILE

10mL (1/3 FL OZ)

Alcon

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

Indulge your eyes in this easy-to-use droppable gel. Systane^® GEL DROPS forms a protective shield over your eyes to provide enduring relief day or night.

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

300048642-0621

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Systane^®

LUBRICANT EYE GEL

GEL DROPS

SOOTHING DRY EYE RELIEF

Long-lasting formula

Day or night protection

#1 DOCTOR RECOMMENDED BRANDS1

LIQUID GEL

STERILE

10mL (1/3 fl oz)

Alcon

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

Country of Origin: Singapore

Indulge your eyes in this easy-to-use droppable gel. Systane® GEL DROPS forms a protective shield over your eyes to provide enduring relief day or night.

ACTUAL SIZE

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

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

300072079-0525

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": "Aminomethylpropanol", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Boric Acid", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Edetate Disodium", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Guaraprolose (3500 Mpa.S At 1%)", "unii": "3A1I7376TC", "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": "Sodium Chloride", "unii": "451W47IQ8X", "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": ""}]

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 protectant against further irritation or to relieve 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": "shake well before using 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": "aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD ® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.", "PRINCIPAL DISPLAY PANEL": "Systane ® LUBRICANT EYE GEL GEL DROPS SOOTHING DRY EYE RELIEF Long-lasting formula Day or night protection #1 DOCTOR RECOMMENDED BRAND 1 LIQUID GEL STERILE 10mL (1/3 FL OZ) Alcon 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 Indulge your eyes in this easy-to-use droppable gel. Systane ® GEL DROPS forms a protective shield over your eyes to provide enduring relief day or night. 1 Based on a survey of eye care professionals. Data on file. 300048642-0621 Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Systane ® LUBRICANT EYE GEL GEL DROPS SOOTHING DRY EYE RELIEF Long-lasting formula Day or night protection #1 DOCTOR RECOMMENDED BRANDS1 LIQUID GEL STERILE 10mL (1/3 fl oz) Alcon 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 Country of Origin: Singapore Indulge your eyes in this easy-to-use droppable gel. Systane® GEL DROPS forms a protective shield over your eyes to provide enduring relief day or night. ACTUAL SIZE 1 Based on a survey of eye care professionals. Data on file. Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 300072079-0525", "When using this product": "do not touch tip of container to any surface to avoid contamination replace cap after each use"}