systane

systane
SPL v11
SPL
SPL Set ID 14916d2c-a63d-491e-bd91-a61f300af38a
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
boric acid calcium chloride guar gum magnesium chloride potassium chloride water sodium chloride zinc chloride hydrochloric acid sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2015-10-30 Until 2017-12-31

Description

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


Medication Information

Warnings

For external use only

Uses
  • For the temporary relief of burning and irritation due to dryness of the eye
Directions
  • instill 1 or 2 drops in the affected eye(s) as needed
Other Information
  • store at room temperature
  • protect from light
Inactive Ingredients

boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride.  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    



ORIGINAL PF

PRESERVATIVE-FREE

DRY EYE RELIEF




Convenient

Single Vials

On-the-Go



Great for Sensitive Eyes

Refreshes & Lubricates

Soothing Comfort



#1 Doctor Recommended Brand1



STERILE

30
Vials 0.7 mL Each



Alcon

Side Panel (s)

SOOTHING COMFORT

SYSTANE® Original PF

Lubricant Eye Drops is scientifically

formulated to shield eyes from

dry eye discomfort so that

eyes feel refreshed.  



LONG-LASTING RELIEF

SYSTANE® Original PF

Lubricant Eye Drops provides

long-lasting dry eye relief.  



PRESERVATIVE-FREE

SYSTANE® Original PF

Lubricant Eye Drops comes in

convenient preservative-free vials

so you can enjoy relief from dry

eye anytime, anywhere.  



TAMPER EVIDENT: 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.



www.alconpatents.com  



Made in France



435241-0819  

Systane®

LUBRICANT EYE DROPS  



ORIGINAL 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.


Manufactured for:

ALCON

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Questions?

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

[email protected]

www.systane.com

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 the temporary relief of burning and irritation due to dryness of the eye
Directions
  • instill 1 or 2 drops in the affected eye(s) as needed
Other Information
  • store at room temperature
  • protect from light
Inactive Ingredients

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

Principal Display Panel

Systane®

LUBRICANT EYE DROPS    



ORIGINAL PF

PRESERVATIVE-FREE

DRY EYE RELIEF




Convenient

Single Vials

On-the-Go



Great for Sensitive Eyes

Refreshes & Lubricates

Soothing Comfort



#1 Doctor Recommended Brand1



STERILE

30
Vials 0.7 mL Each



Alcon

Side Panel (s)

SOOTHING COMFORT

SYSTANE® Original PF

Lubricant Eye Drops is scientifically

formulated to shield eyes from

dry eye discomfort so that

eyes feel refreshed.  



LONG-LASTING RELIEF

SYSTANE® Original PF

Lubricant Eye Drops provides

long-lasting dry eye relief.  



PRESERVATIVE-FREE

SYSTANE® Original PF

Lubricant Eye Drops comes in

convenient preservative-free vials

so you can enjoy relief from dry

eye anytime, anywhere.  



TAMPER EVIDENT: 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.



www.alconpatents.com  



Made in France



435241-0819  

Systane®

LUBRICANT EYE DROPS  



ORIGINAL 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.


Manufactured for:

ALCON

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Questions?

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

[email protected]

www.systane.com

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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