drug facts

drug facts
SPL v14
SPL
SPL Set ID 15bc06ec-f3dc-3180-ca1a-106769a770ea
Route
ophthalmic
Published
Effective Date 2023-12-15
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
boric acid calcium chloride guar gum magnesium chloride polidronium chloride potassium chloride water sodium chloride zinc chloride hydrochloric acid sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2003-02-25 Until 2018-04-30

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
  • put 1 or 2 drops in the affected eye(s) as needed
Other Information
  • store at room temperature
Description

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

Principal Display Panel

Systane ®

LUBRICANT EYE DROPS



ORIGINAL

LONG-LASTING 

DRY EYE RELIEF   



Refreshes & Lubricates

Soothing Comfort



#1 DOCTOR RECOMMENDED BRAND1



Alcon
 

STERILE

15 mL (1/2 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.



Enjoy lasting comfort with SYSTANE® Lubricant Eye Drops.



SYSTANE® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.



ACTUAL SIZE



Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



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



www.alconpatents.com

Made in USA from domestic and imported materials



9016879-1118




LOT:                EXP:

Systane®

LUBRICANT EYE DROPS

ORIGINAL LONG-LASTING

DRY EYE RELIEF



Refreshes & Lubricates

Soothing Comfort



#1 DOCTOR RECOMMENDED BRAND 1



Alcon

STERILE

15 mL (1/2 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.



Enjoy lasting comfort with SYSTANE® Lubricant Eye Drops.



SYSTANE® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.



ACTUAL SIZE



Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



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



www.alconpatents.com

Country of Origin: Singapore



SC00264-0219



LOT:          EXP:

Questions?

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

[email protected]



www.systane.com

Section 50565-1

Keep out of reach of children.

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

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
Inactive Ingredients:

Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, polyquaternium-1 as a preservative, potassium chloride, purified water, sodium chloride, zinc chloride.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

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

Structured Label Content

Warnings

For external use only

Uses
  • For the temporary relief of burning and irritation due to dryness of the eye
Directions
  • put 1 or 2 drops in the affected eye(s) as needed
Other Information
  • store at room temperature
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Systane ®

LUBRICANT EYE DROPS



ORIGINAL

LONG-LASTING 

DRY EYE RELIEF   



Refreshes & Lubricates

Soothing Comfort



#1 DOCTOR RECOMMENDED BRAND1



Alcon
 

STERILE

15 mL (1/2 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.



Enjoy lasting comfort with SYSTANE® Lubricant Eye Drops.



SYSTANE® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.



ACTUAL SIZE



Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



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



www.alconpatents.com

Made in USA from domestic and imported materials



9016879-1118




LOT:                EXP:

Systane®

LUBRICANT EYE DROPS

ORIGINAL LONG-LASTING

DRY EYE RELIEF



Refreshes & Lubricates

Soothing Comfort



#1 DOCTOR RECOMMENDED BRAND 1



Alcon

STERILE

15 mL (1/2 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.



Enjoy lasting comfort with SYSTANE® Lubricant Eye Drops.



SYSTANE® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.



ACTUAL SIZE



Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



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



www.alconpatents.com

Country of Origin: Singapore



SC00264-0219



LOT:          EXP:

Questions?

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

[email protected]



www.systane.com

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 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
Inactive Ingredients:

Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, polyquaternium-1 as a preservative, potassium chloride, purified water, sodium chloride, zinc chloride.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)