Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 8936f66f-10fe-44ab-a26e-dd8b05dfa997
Route
OPHTHALMIC
Published
Effective Date 2025-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol, Unspecified (4 mg) Propylene Glycol (3 mg)
Inactive Ingredients
Aminomethylpropanol Boric Acid Guaraprolose (3500 Mpa.s At 1%) Potassium Chloride Water Sodium Borate Sodium Chloride Hyaluronate Sodium Hydrochloric Acid Sodium Hydroxide Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-01

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 use as a protectant against further irritation or to relieve dryness of the eye
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
  • put 1 or 2 drops in the affected eye(s) as needed. 
  • see side of carton for directions for 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]

Directions for Use:

  • Hold the bottle just below the cap and twist the cap to open.
  • BEFORE FIRST USE, hold the bottle upside down and dispense one drop of product to discard.
  • Shake the bottle downward to remove residual product (see picture).
  • Place 1 or 2 drops in the affected eye(s) as needed and blink.
  • After use, shake the bottle downward to remove residual product that may be left on the tip (see picture above).
  • Replace cap after use.
  • Discard 90 days after opening.
Other Information
  • store at room temperature
Inactive Ingredients

aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

Preservative-Free



SYSTANE ®

Lubricant Eye Drops



HYDRATION PF

LONG LASTING

DRY EYE RELIEF



Dual Action Hydration



Extended Moisturizing



Preservative-Free Bottle



#1 Doctor Recommended Brands1



Alcon



STERILE 10 mL (0.34 FL OZ)



Side Panel



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.



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Country of Origin: USA

U.S. Pat: www.alconpatents.com



300068248-0824

Preservative-Free Bottle



SYSTANE®

Lubricant Eye Drops
 



HYDRATION PF
 

PRESERVATIVE-FREE

DRY EYE RELIEF
    



Extra moisturizing for sensitive eyes   

Longer lasting hydration*



#1 Doctor Recommended Brand1



Hydro Boost Technology



Alcon



STERILE 10 mL (0.34 FL OZ)  



Side Panel



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.   

*vs SYSTANE® ULTRA Lubricant Eye Drops     



Alcon Laboratories, Inc.   

Fort Worth, TX 76134 USA   

Country of Origin Belgium   

www.alconpatents.com



300046319-0521

Preservative-Free



SYSTANE®

Lubricant Eye Drops



HYDRATION PF

LONG LASTING

DRY EYE RELIEF



Dual Action Hydration



Extended Moisturizing



Preservative-Free Bottle



#1 Doctor Recommended Brands1



Alcon



STERILE 10 mL (0.34 fl oz)



Side Panel



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.



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Country of Origin: Singapore

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



300072081-0525

SYSTANE ®

Lubricant Eye Drops



HYDRATION PF



LONG LASTING

DRY EYE RELIEF



STERILE

10mL (0.34 FL OZ)



Only for use in the eye.

Store at room temperature.



Discard 90 days after opening.



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.



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



See Carton for Directions For Use.

Country of Origin: USA



LOT:               EXP:



300068256-0824

SYSTANE ®

Lubricant Eye Drops



HYDRATION PF

LONG LASTING


DRY EYE RELIEF



STERILE

10mL (0.34 fl oz)



Only for use in the eye.

Store at room temperature.



Discard 90 days after opening.



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.



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



See Carton for Directions For Use.



Country of Origin: Singapore



LOT:               EXP:



300072094-0525

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

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • for use as a protectant against further irritation or to relieve dryness of the eye
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
  • put 1 or 2 drops in the affected eye(s) as needed. 
  • see side of carton for directions for use
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]

Directions for Use:

  • Hold the bottle just below the cap and twist the cap to open.
  • BEFORE FIRST USE, hold the bottle upside down and dispense one drop of product to discard.
  • Shake the bottle downward to remove residual product (see picture).
  • Place 1 or 2 drops in the affected eye(s) as needed and blink.
  • After use, shake the bottle downward to remove residual product that may be left on the tip (see picture above).
  • Replace cap after use.
  • Discard 90 days after opening.
Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Preservative-Free



SYSTANE ®

Lubricant Eye Drops



HYDRATION PF

LONG LASTING

DRY EYE RELIEF



Dual Action Hydration



Extended Moisturizing



Preservative-Free Bottle



#1 Doctor Recommended Brands1



Alcon



STERILE 10 mL (0.34 FL OZ)



Side Panel



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.



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Country of Origin: USA

U.S. Pat: www.alconpatents.com



300068248-0824

Preservative-Free Bottle



SYSTANE®

Lubricant Eye Drops
 



HYDRATION PF
 

PRESERVATIVE-FREE

DRY EYE RELIEF
    



Extra moisturizing for sensitive eyes   

Longer lasting hydration*



#1 Doctor Recommended Brand1



Hydro Boost Technology



Alcon



STERILE 10 mL (0.34 FL OZ)  



Side Panel



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.   

*vs SYSTANE® ULTRA Lubricant Eye Drops     



Alcon Laboratories, Inc.   

Fort Worth, TX 76134 USA   

Country of Origin Belgium   

www.alconpatents.com



300046319-0521

Preservative-Free



SYSTANE®

Lubricant Eye Drops



HYDRATION PF

LONG LASTING

DRY EYE RELIEF



Dual Action Hydration



Extended Moisturizing



Preservative-Free Bottle



#1 Doctor Recommended Brands1



Alcon



STERILE 10 mL (0.34 fl oz)



Side Panel



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.



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Country of Origin: Singapore

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



300072081-0525

SYSTANE ®

Lubricant Eye Drops



HYDRATION PF



LONG LASTING

DRY EYE RELIEF



STERILE

10mL (0.34 FL OZ)



Only for use in the eye.

Store at room temperature.



Discard 90 days after opening.



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.



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



See Carton for Directions For Use.

Country of Origin: USA



LOT:               EXP:



300068256-0824

SYSTANE ®

Lubricant Eye Drops



HYDRATION PF

LONG LASTING


DRY EYE RELIEF



STERILE

10mL (0.34 fl oz)



Only for use in the eye.

Store at room temperature.



Discard 90 days after opening.



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.



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



See Carton for Directions For Use.



Country of Origin: Singapore



LOT:               EXP:



300072094-0525

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
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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