drug facts

drug facts
SPL v7
SPL
SPL Set ID db3a6c68-320b-46b0-83fa-6c29297a84a6
Route
ophthalmic
Published
Effective Date 2023-12-15
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 2020-02-01

Description

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


Medication Information

Warnings

For external use only                 

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

Description

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

Principal Display Panel

SYSTANE®

Lubricant Eye Drops




HYDRATION PF

PRESERVATIVE-FREE

DRY EYE RELIEF



Convenient

Single Vials

On-the-Go



Extra moisturizing for sensitive eyes



Longer lasting hydration*



VOTED PRODUCT OF THE YEAR

Consumer Survey of Product Innovation

2021±



Hydro

Boost


TECHNOLOGY



Alcon



STERILE

30
Vials 0.7 mL (0.02 FL OZ)



Experience

preservative-free

relief that’s extra

moisturizing for

sensitive eyes 




Common Dry Eye Symptoms

• Burning or stinging

• Fluctuating vision

• Irritation

• Watery eyes



TAMPER EVIDENT:

For your protection, do not use if vial is damaged or opened at time of purchase.



1 Based on a survey of eye care professionals.

Data on file.



* vs SYSTANE® ULTRA Lubricant Eye Drops



±Winner Eye Care Category. Survey of 40,000

people by Kantar.



www.alconpatents.com

Made in France 



436272-0221



SYSTANE® Lubricant Eye Drops



HYDRATION PF

PRESERVATIVE-FREE

DRY EYE RELIEF



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



LOT:

EXP.: 


Questions?

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

www.systane.com

[email protected]

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
Do Not Use
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
When Using This Product
  • do not touch tip of container to any surface to avoid contamination
  • do not reuse
  • once opened, discard

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only                 

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

SYSTANE®

Lubricant Eye Drops




HYDRATION PF

PRESERVATIVE-FREE

DRY EYE RELIEF



Convenient

Single Vials

On-the-Go



Extra moisturizing for sensitive eyes



Longer lasting hydration*



VOTED PRODUCT OF THE YEAR

Consumer Survey of Product Innovation

2021±



Hydro

Boost


TECHNOLOGY



Alcon



STERILE

30
Vials 0.7 mL (0.02 FL OZ)



Experience

preservative-free

relief that’s extra

moisturizing for

sensitive eyes 




Common Dry Eye Symptoms

• Burning or stinging

• Fluctuating vision

• Irritation

• Watery eyes



TAMPER EVIDENT:

For your protection, do not use if vial is damaged or opened at time of purchase.



1 Based on a survey of eye care professionals.

Data on file.



* vs SYSTANE® ULTRA Lubricant Eye Drops



±Winner Eye Care Category. Survey of 40,000

people by Kantar.



www.alconpatents.com

Made in France 



436272-0221



SYSTANE® Lubricant Eye Drops



HYDRATION PF

PRESERVATIVE-FREE

DRY EYE RELIEF



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



LOT:

EXP.: 


Questions?

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

www.systane.com

[email protected]

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
Do Not Use (Do not use)
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
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

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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