Systane Complete Pf Preservative Free- Propylene Glycol Emulsion

Drug Facts

Composition & Product

Active Ingredients

Propylene Glycol (.06 mg)

Inactive Ingredients

Boric Acid Dimyristoylphosphatidylglycerol, Dl- Guaraprolose (3500 Mpa.s At 1%) Mineral Oil Polyoxyl 40 Stearate Sorbitan Tristearate Sorbitol Water Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-02-01

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

Questions?

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

www.systane.com

[email protected]

437600

Other Information

store at room temperature

Inactive Ingredients

boric acid, dimyristoyl phosphatidylglycerol, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Made in France

www.alconpatents.com

NDC: 0065-1530-01

437600

SAMPLE-NOT FOR SALE

Systane ^®

LUBRICANT EYE DROP

COMPLETE PF

PRESERVATIVE-FREE

DRY EYE RELIEF

Fast-acting hydration for sensitive eyes

Tear evaporation protection

Nano-droplets for better coverage*

Only available at retail in a preservative-free bottle

#1 DOCTOR RECOMMENDED BRAND¹

Alcon

STERILE

5 Vials 0.5 mL (0.01 FL OZ) each

Side Panel:

Exclusive Formula Not Sold in Store Brands

DIRECTIONS: Make sure container is intact before use.

To open, COMPLETELY TWIST OFF TAB. Do not pull off. Put 1 or 2 drops in the affected eye(s) as needed.

Throw away container. Do not reuse.

TAMPER EVIDENT: For your protection, do not use if vial is damaged or opened.

437600

¹Based on a survey of eye care professionals.

Data on file.

*vs SYSTANE^® BALANCE

LOT :

EXP:

2737

NDC: 0065-1530-04

439260

Systane ^®

LUBRICANT EYE DROPS

COMPLETE PF

PRESERVATIVE-FREE

DRY EYE RELIEF

Convenient

Single Vial

On-the-Go

Fast-acting hydration for sensitive eyes

Tear evaporation protection

DOCTOR RECOMMENDED #1 BRAND¹

Alcon

Sterile

30 Vials 0.5mL (0.01 FL OZ) each

Side Panel:

DIRECTIONS:

Make sure container is intact before use.

To open, COMPLETELY TWIST OFF TAB.

Do not pull off.

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

Throw away container. Do not reuse.

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

SYSTANE ^® COMPLETE

Lubricant Eye Drops

hydrates fast, protects against tear evaporation, and helps support all layers of the tear film

TAMPER EVIDENT: For your protection, this bottle has a tamper evident ring around the bottom of the cap.

Do not use if this ring is damaged or missing at the time of purchase.

¹Based on a survey of eye care professionals.

Data on file.

U.S. Pat.:www.alconpatents.com

Made in France

439260-0423

LOT :

EXP.:

439260

When Using This Product

do not touch tip of container to any surface to avoid contamination
do not reuse
once opened, discard

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

Questions?

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

www.systane.com

[email protected]

437600

Other Information

store at room temperature

Inactive Ingredients

boric acid, dimyristoyl phosphatidylglycerol, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Made in France

www.alconpatents.com

NDC: 0065-1530-01

437600

SAMPLE-NOT FOR SALE

Systane ^®

LUBRICANT EYE DROP

COMPLETE PF

PRESERVATIVE-FREE

DRY EYE RELIEF

Fast-acting hydration for sensitive eyes

Tear evaporation protection

Nano-droplets for better coverage*

Only available at retail in a preservative-free bottle

#1 DOCTOR RECOMMENDED BRAND¹

Alcon

STERILE

5 Vials 0.5 mL (0.01 FL OZ) each

Side Panel:

Exclusive Formula Not Sold in Store Brands

DIRECTIONS: Make sure container is intact before use.

To open, COMPLETELY TWIST OFF TAB. Do not pull off. Put 1 or 2 drops in the affected eye(s) as needed.

Throw away container. Do not reuse.

TAMPER EVIDENT: For your protection, do not use if vial is damaged or opened.

437600

¹Based on a survey of eye care professionals.

Data on file.

*vs SYSTANE^® BALANCE

LOT :

EXP:

2737

NDC: 0065-1530-04

439260

Systane ^®

LUBRICANT EYE DROPS

COMPLETE PF

PRESERVATIVE-FREE

DRY EYE RELIEF

Convenient

Single Vial

On-the-Go

Fast-acting hydration for sensitive eyes

Tear evaporation protection

DOCTOR RECOMMENDED #1 BRAND¹

Alcon

Sterile

30 Vials 0.5mL (0.01 FL OZ) each

Side Panel:

DIRECTIONS:

Make sure container is intact before use.

To open, COMPLETELY TWIST OFF TAB.

Do not pull off.

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

Throw away container. Do not reuse.

Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

SYSTANE ^® COMPLETE

Lubricant Eye Drops

hydrates fast, protects against tear evaporation, and helps support all layers of the tear film

TAMPER EVIDENT: For your protection, this bottle has a tamper evident ring around the bottom of the cap.

Do not use if this ring is damaged or missing at the time of purchase.

¹Based on a survey of eye care professionals.

Data on file.

U.S. Pat.:www.alconpatents.com

Made in France

439260-0423

LOT :

EXP.:

439260

When Using This Product (When using this product)

do not touch tip of container to any surface to avoid contamination
do not reuse
once opened, discard

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": "Guaraprolose (3500 Mpa.S At 1%)", "unii": "3A1I7376TC", "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": ""}]

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 or becomes cloudy if you are sensitive to any ingredient in this product", "Questions?": "In the U.S. call 1-800-757-9195 www.systane.com alcon.medinfo@alcon.com 437600", "Other Information": "store at room temperature", "Inactive Ingredients": "boric acid, dimyristoyl phosphatidylglycerol, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.", "PRINCIPAL DISPLAY PANEL": "Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Made in France www.alconpatents.com NDC: 0065-1530-01 437600 SAMPLE-NOT FOR SALE Systane ® LUBRICANT EYE DROP COMPLETE PF PRESERVATIVE-FREE DRY EYE RELIEF Fast-acting hydration for sensitive eyes Tear evaporation protection Nano-droplets for better coverage* Only available at retail in a preservative-free bottle #1 DOCTOR RECOMMENDED BRAND 1 Alcon STERILE 5 Vials 0.5 mL (0.01 FL OZ) each Side Panel: Exclusive Formula Not Sold in Store Brands DIRECTIONS: Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB. Do not pull off. Put 1 or 2 drops in the affected eye(s) as needed. Throw away container. Do not reuse. TAMPER EVIDENT: For your protection, do not use if vial is damaged or opened. 437600 1 Based on a survey of eye care professionals. Data on file. *vs SYSTANE ® BALANCE LOT : EXP: 2737 NDC: 0065-1530-04 439260 Systane ® LUBRICANT EYE DROPS COMPLETE PF PRESERVATIVE-FREE DRY EYE RELIEF Convenient Single Vial On-the-Go Fast-acting hydration for sensitive eyes Tear evaporation protection DOCTOR RECOMMENDED #1 BRAND 1 Alcon Sterile 30 Vials 0.5mL (0.01 FL OZ) each Side Panel: DIRECTIONS: Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB. Do not pull off. Put 1 or 2 drops in the affected eye(s) as needed. Throw away container. Do not reuse. Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA SYSTANE ® COMPLETE Lubricant Eye Drops hydrates fast, protects against tear evaporation, and helps support all layers of the tear film TAMPER EVIDENT: For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase. 1 Based on a survey of eye care professionals. Data on file. U.S. Pat.:www.alconpatents.com Made in France 439260-0423 LOT : EXP.: 439260", "When using this product": "do not touch tip of container to any surface to avoid contamination do not reuse once opened, discard"}

Systane Complete Pf Preservative Free- Propylene Glycol Emulsion

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information