Drug Facts

Drug Facts
SPL v15
SPL
SPL Set ID a5c1c194-3db5-4f18-9cd1-97f7f84c3cff
Route
OPHTHALMIC
Published
Effective Date 2022-07-07
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 Guar Gum Potassium Chloride Water Sodium Chloride Sorbitol Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2009-07-27 Until 2017-12-31

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 temporary relief of discomfort due to minor irritation of the eye or to exposure to wind or sun

Section 50565-1

Keep out of reach of children.

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

Section 55106-9
Active Ingredients Purpose
Polyethylene Glycol 400 0.4% Lubricant
Propylene Glycol 0.3% Lubricant
Directions
  • Put 1 or 2 drops in the affected eye(s) as needed.
Questions?

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

www.systane.com

Other Information
  • Store at room temperature
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.

Principal Display Panel

Systane ®

LUBRICANT EYE DROPS    



ULTRA PF




PRESERVATIVE-FREE

DRY EYE RELIEF



Convenient Single Vials On-The-Go



Great for sensitive eyes



Fast-acting hydration

and lasting relief



Moisture-rich formula



#1 Doctor Recommended Brand1



STERILE

60 Vials 0.7 mL Each



Alcon

SIDE DISPLAY PANEL

Systane®

LUBRICANT EYE DROPS



ULTRA PF



PRESERVATIVE-FREE

DRY EYE RELIEF



Convenient Single Vials On-The-Go



Open your eyes to a

breakthrough in comfort with

SYSTANE® ULTRA Lubricant Eye Drops.



SYSTANE® ULTRA preservative-free vials

elevates the science of dry eye therapy

to a new level so you can have relief

from dry eye anytime, anywhere.



From first blink eyes feel lubricated

and refreshed.



Feel the difference in dry eye relief

with SYSTANE ® ULTRA



TAMPER EVIDENT:

Do not use if vial is damaged or opened at time of purchase.



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



www.alconpatents.com

Made in France



W435221-0919

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


Structured Label Content

Uses
  • For the temporary relief of burning and irritation due to dryness of the eye
  • for temporary relief of discomfort due to minor irritation of the eye or to exposure to wind or sun

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 55106-9 (55106-9)
Active Ingredients Purpose
Polyethylene Glycol 400 0.4% Lubricant
Propylene Glycol 0.3% Lubricant
Directions
  • Put 1 or 2 drops in the affected eye(s) as needed.
Questions?

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

www.systane.com

Other Information
  • Store at room temperature
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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Systane ®

LUBRICANT EYE DROPS    



ULTRA PF




PRESERVATIVE-FREE

DRY EYE RELIEF



Convenient Single Vials On-The-Go



Great for sensitive eyes



Fast-acting hydration

and lasting relief



Moisture-rich formula



#1 Doctor Recommended Brand1



STERILE

60 Vials 0.7 mL Each



Alcon

SIDE DISPLAY PANEL

Systane®

LUBRICANT EYE DROPS



ULTRA PF



PRESERVATIVE-FREE

DRY EYE RELIEF



Convenient Single Vials On-The-Go



Open your eyes to a

breakthrough in comfort with

SYSTANE® ULTRA Lubricant Eye Drops.



SYSTANE® ULTRA preservative-free vials

elevates the science of dry eye therapy

to a new level so you can have relief

from dry eye anytime, anywhere.



From first blink eyes feel lubricated

and refreshed.



Feel the difference in dry eye relief

with SYSTANE ® ULTRA



TAMPER EVIDENT:

Do not use if vial is damaged or opened at time of purchase.



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



www.alconpatents.com

Made in France



W435221-0919

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
For External Use Only.  do Not Use (For external use only.  Do not use)
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
Stop Use and Ask A Doctor If You Experience Any of the Following: (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)