Drug Facts

Drug Facts
SPL v19
SPL
SPL Set ID 0537c23a-15f7-be64-1231-a6c93468e9a8
Route
OPHTHALMIC
Published
Effective Date 2025-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (4 mg) Propylene Glycol (3 mg)
Inactive Ingredients
Aminomethylpropanol Boric Acid Guar Gum Polidronium Chloride Potassium Chloride Water Sodium Chloride Sorbitol Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-01

Description

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


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 the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Principal Display Panel

Systane®

LUBRICANT EYE DROPS



ULTRA

HIGH PERFORMING

DRY EYE RELIEF




Fast-acting hydration

and lasting relief

Moisture rich formula



#1 Doctor Recommended Brand1



Alcon STERILE 

10mL (1/3 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.



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

Country Of Origin: Singapore



Open your eyes to a breakthrough in comfort with Systane® ULTRA Lubricant Eye Drops.



From first blink, eyes feel lubricated and refreshed. Feel the difference in dry eye relief with SYSTANE® ULTRA.



ACTUAL SIZE  



Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



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



300068356-0924

Systane®

LUBRICANT EYE DROPS



ULTRA

HIGH PERFORMING

DRY EYE RELIEF




Fast-acting hydration

and lasting relief

Moisture rich formula



#1 Doctor Recommended Brand1 Alcon STERILE 

10mL (1/3 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.



www.alconpatents.com

Made in USA from domestic and imported materials.



Open your eyes to a breakthrough in comfort with Systane® ULTRA Lubricant Eye Drops.



From first blink, eyes feel lubricated and refreshed.



Feel the difference in dry eye relief with SYSTANE® ULTRA.



ACTUAL SIZE  



Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



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



300051246-1221

When Using This Product
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
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

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Systane®

LUBRICANT EYE DROPS



ULTRA

HIGH PERFORMING

DRY EYE RELIEF




Fast-acting hydration

and lasting relief

Moisture rich formula



#1 Doctor Recommended Brand1



Alcon STERILE 

10mL (1/3 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.



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

Country Of Origin: Singapore



Open your eyes to a breakthrough in comfort with Systane® ULTRA Lubricant Eye Drops.



From first blink, eyes feel lubricated and refreshed. Feel the difference in dry eye relief with SYSTANE® ULTRA.



ACTUAL SIZE  



Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



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



300068356-0924

Systane®

LUBRICANT EYE DROPS



ULTRA

HIGH PERFORMING

DRY EYE RELIEF




Fast-acting hydration

and lasting relief

Moisture rich formula



#1 Doctor Recommended Brand1 Alcon STERILE 

10mL (1/3 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.



www.alconpatents.com

Made in USA from domestic and imported materials.



Open your eyes to a breakthrough in comfort with Systane® ULTRA Lubricant Eye Drops.



From first blink, eyes feel lubricated and refreshed.



Feel the difference in dry eye relief with SYSTANE® ULTRA.



ACTUAL SIZE  



Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



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



300051246-1221

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
Stop Use and Ask A Doctor If (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)