FDA Label for Systane Pro Pf

View Indications, Usage & Precautions

Systane Pro Pf Product Label

The following document was submitted to the FDA by the labeler of this product Alcon Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Purpose



Active IngredientsPurpose
Propylene Glycol 0.6%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
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for use as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings



For external use only


Do Not Use



  • if this product changes color
  • 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
  • replace cap after each use

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

Keep Out Of Reach Of Children.



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


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

Other Information



  • store at room temperature

Inactive Ingredients



boric acid, dimyristoyl phosphatidylglycerol, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, sodium hyaluronate, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.


Questions?



In the U.S. call 1-800-757-9195
www.systane.com
[email protected]


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 on side panel).
  • Replace cap after use.
  • Discard 30 days after opening.

Principal Display Panel



Preservative-Free

Systane® LUBRICANT EYE DROPS

PRO PF
TRIPLE ACTION
DRY EYE RELIEF

Hydrates, Restores, Protects

Long-Lasting

With Hyaluronate

Preservative-Free Bottle

#1 DOCTOR RECOMMENDED BRANDS1

Alcon

Sterile
10mL (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

Actual Size

300066249-0524

TWIN VALUE PACK

Preservative-Free

Systane® LUBRICANT EYE DROPS

PRO PF
TRIPLE ACTION
DRY EYE RELIEF

Hydrates, Restores, Protects

Long-Lasting

With Hyaluronate

Preservative-Free Bottles

#1 DOCTOR RECOMMENDED BRANDS1

Alcon

Sterile
Two 10mL (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.

ACTUAL SIZE

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin United States
U.S. Pat.: www.alconpatents.com

300066250-0924

Systane® LUBRICANT EYE DROPS

PRO PF
TRIPLE ACTION
DRY EYE RELIEF


10mL (0.34 FL OZ)
Sterile

See Carton for Directions for Use.

Country of Origin: USA

Only for use in the eye

Store at room temperature.

Discard 30 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

300066375-0524


* Please review the disclaimer below.