Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 751fb85f-6683-4b0a-a650-324d4a74c5de
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 Guaraprolose (3500 Mpa.s At 1%) Potassium Chloride Water Sodium Chloride Sorbitol Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-15

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 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
  • 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

[email protected]

www.systane.com



Other Information
  • Store at room temperature
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.

Inactive Ingredients

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

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

Preservative-Free



Systane®

LUBRICANT EYE DROPS



ULTRA PF

FAST ACTING

DRY EYE RELIEF



Moisture Rich Formula

Instantly Hydrates



Preservative-Free Bottle



DOCTOR RECOMMENDED #1 BRANDS1



Alcon



STERILE

10 mL (0.34 FL OZ)



LOT:                                         EXP.:



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 United States

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



300068254-0824



Actual Size

TWIN VALUE PACK



Preservative-Free



Systane®

LUBRICANT EYE DROPS



ULTRA PF

FAST ACTING

DRY EYE RELIEF



Moisture Rich Formula

Instantly Hydrates



Preservative-Free Bottles



DOCTOR RECOMMENDED #1 BRANDS1



Alcon



STERILE

Two 10 mL (0.34 FL OZ) Bottles



LOT:                                         EXP.:



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.



Preservative-Free

Fast Acting

Relief for

Sensitive Eyes



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Country of Origin USA

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



ACTUAL SIZE



300068255-0824



Preservative-Free



Systane
®

LUBRICANT EYE DROPS



ULTRA PF

FAST ACTING


DRY EYE RELIEF



Moisture Rich Formula

Instantly Hydrates



Preservative-Free Bottle



DOCTOR RECOMMENDED #1 BRANDS1



Alcon



STERILE

10 mL (0.34 fl oz)



LOT:                                         EXP.:



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: Singapore

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



300072082-0525 



Actual Size

Systane ®

LUBRICANT EYE DROPS



ULTRA PF


FAST ACTING

DRY EYE RELIEF



10 mL (0.34 FL OZ) STERILE   



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:



300068258-0824

Keep Out of Reach of Children.

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


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 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
  • 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

[email protected]

www.systane.com



Other Information
  • Store at room temperature
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.

Inactive Ingredients (Inactive ingredients)

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

When Using the Product (When using the product)
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Preservative-Free



Systane®

LUBRICANT EYE DROPS



ULTRA PF

FAST ACTING

DRY EYE RELIEF



Moisture Rich Formula

Instantly Hydrates



Preservative-Free Bottle



DOCTOR RECOMMENDED #1 BRANDS1



Alcon



STERILE

10 mL (0.34 FL OZ)



LOT:                                         EXP.:



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 United States

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



300068254-0824



Actual Size

TWIN VALUE PACK



Preservative-Free



Systane®

LUBRICANT EYE DROPS



ULTRA PF

FAST ACTING

DRY EYE RELIEF



Moisture Rich Formula

Instantly Hydrates



Preservative-Free Bottles



DOCTOR RECOMMENDED #1 BRANDS1



Alcon



STERILE

Two 10 mL (0.34 FL OZ) Bottles



LOT:                                         EXP.:



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.



Preservative-Free

Fast Acting

Relief for

Sensitive Eyes



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Country of Origin USA

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



ACTUAL SIZE



300068255-0824



Preservative-Free



Systane
®

LUBRICANT EYE DROPS



ULTRA PF

FAST ACTING


DRY EYE RELIEF



Moisture Rich Formula

Instantly Hydrates



Preservative-Free Bottle



DOCTOR RECOMMENDED #1 BRANDS1



Alcon



STERILE

10 mL (0.34 fl oz)



LOT:                                         EXP.:



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: Singapore

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



300072082-0525 



Actual Size

Systane ®

LUBRICANT EYE DROPS



ULTRA PF


FAST ACTING

DRY EYE RELIEF



10 mL (0.34 FL OZ) STERILE   



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:



300068258-0824

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

All Sections (JSON)