Systane Complete Lubricant Eye Drops

Drug Facts

Composition & Product

Active Ingredients

Propylene Glycol (.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 2018-01-18

Medication Information

Description

Active Ingredients Purpose Propylene Glycol 0.6% Lubricant

Uses

for the temporary relief of burning and irritation due to dryness of the eye
for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
for use as a protectant against further irritation or to relieve dryness of the eye
for use as a lubricant to prevent 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 55106-9

Active Ingredients	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

COMPLETE

OPTIMAL DRY EYE RELIEF

Fast-acting hydration

Tear evaporation protection

Nano-droplets for better coverage*

#1 DOCTOR RECOMMENDED BRAND¹

nano droplet

Alcon

STERILE

10mL (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.

SYSTANE^®

COMPLETE

Our most advanced

formula ever!

SYSTANE^®

COMPLETE

Lubricant

Eye Drops

hydrates

fast, protects

against tear

evaporation, and

helps support all layers

of the tear film.

Nano droplet technology:*

● a better delivery of the

active ingredient

● better eye coverage

ACTUAL SIZE

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76143 USA

* vs SYSTANE^® BALANCE

¹Based on a survey of eye care professionals.

Data on file.

www.alconpatents.com

Made in USA from domestic and imported materials

300048645-0621

Systane^®

LUBRICANT EYE DROPS

COMPLETE

MULTI-SYMPTOM

DRY EYE RELIEF

All-in-One Formula

Tear Evaporation Protection

#1 DOCTOR RECOMMENDED BRANDS¹

Alcon

STERILE

10mL (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.

SYSTANE^®

COMPLETE

SYSTANE^®

COMPLETE

Lubricant

Eye Drops

hydrates

fast, protects

against tear

evaporation, and

helps support all layers

of the tear film.

ACTUAL SIZE

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76143 USA

¹Based on a survey of eye care professionals.

Data on file.

www.alconpatents.com

Country of Origin: Singapore

300072080-0525

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 the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
for use as a protectant against further irritation or to relieve dryness of the eye
for use as a lubricant to prevent 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 55106-9 (55106-9)

Active Ingredients	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

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 (PRINCIPAL DISPLAY PANEL)

Systane ^®

LUBRICANT EYE DROPS

COMPLETE

OPTIMAL DRY EYE RELIEF

Fast-acting hydration

Tear evaporation protection

Nano-droplets for better coverage*

#1 DOCTOR RECOMMENDED BRAND¹

nano droplet

Alcon

STERILE

10mL (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.

SYSTANE^®

COMPLETE

Our most advanced

formula ever!

SYSTANE^®

COMPLETE

Lubricant

Eye Drops

hydrates

fast, protects

against tear

evaporation, and

helps support all layers

of the tear film.

Nano droplet technology:*

● a better delivery of the

active ingredient

● better eye coverage

ACTUAL SIZE

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76143 USA

* vs SYSTANE^® BALANCE

¹Based on a survey of eye care professionals.

Data on file.

www.alconpatents.com

Made in USA from domestic and imported materials

300048645-0621

Systane^®

LUBRICANT EYE DROPS

COMPLETE

MULTI-SYMPTOM

DRY EYE RELIEF

All-in-One Formula

Tear Evaporation Protection

#1 DOCTOR RECOMMENDED BRANDS¹

Alcon

STERILE

10mL (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.

SYSTANE^®

COMPLETE

SYSTANE^®

COMPLETE

Lubricant

Eye Drops

hydrates

fast, protects

against tear

evaporation, and

helps support all layers

of the tear film.

ACTUAL SIZE

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76143 USA

¹Based on a survey of eye care professionals.

Data on file.

www.alconpatents.com

Country of Origin: Singapore

300072080-0525

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": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": ".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 the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun for use as a protectant against further irritation or to relieve dryness of the eye for use as a lubricant to prevent 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", "55106-9": "Active Ingredients 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 COMPLETE OPTIMAL DRY EYE RELIEF Fast-acting hydration Tear evaporation protection Nano-droplets for better coverage* #1 DOCTOR RECOMMENDED BRAND 1 nano droplet Alcon STERILE 10mL (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. SYSTANE ® COMPLETE Our most advanced formula ever! SYSTANE ® COMPLETE Lubricant Eye Drops hydrates fast, protects against tear evaporation, and helps support all layers of the tear film. Nano droplet technology:* ● a better delivery of the active ingredient ● better eye coverage ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76143 USA * vs SYSTANE ® BALANCE 1 Based on a survey of eye care professionals. Data on file. www.alconpatents.com Made in USA from domestic and imported materials 300048645-0621 Systane ® LUBRICANT EYE DROPS COMPLETE MULTI-SYMPTOM DRY EYE RELIEF All-in-One Formula Tear Evaporation Protection #1 DOCTOR RECOMMENDED BRANDS 1 Alcon STERILE 10mL (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. SYSTANE ® COMPLETE SYSTANE ® COMPLETE Lubricant Eye Drops hydrates fast, protects against tear evaporation, and helps support all layers of the tear film. ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76143 USA 1 Based on a survey of eye care professionals. Data on file. www.alconpatents.com Country of Origin: Singapore 300072080-0525", "When using this product": "do not touch tip of container to any surface to avoid contamination replace cap after each use"}

Systane Complete Lubricant Eye Drops

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information