Systane Pro Preservative Free

Systane Pro Preservative Free
SPL v3
SPL
SPL Set ID 23b3515f-fbe5-4398-b2df-8b2eccdd01e2
Route
OPHTHALMIC
Published
Effective Date 2025-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Propylene Glycol (6 mg)
Inactive Ingredients
Boric Acid Dimyristoylphosphatidylglycerol, Dl- Guaraprolose (3500 Mpa.s At 1%) Mineral Oil Polyoxyl 40 Stearate Type I Hyaluronate Sodium Sorbitan Tristearate Sorbitol Water Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-31

Description

Active Ingredients Purpose Propylene Glycol 0.6% Lubricant


Medication Information

Description

Active Ingredients Purpose 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
Section 55105-1
Active Ingredients Purpose
Propylene Glycol 0.6% Lubricant
Warnings

For external use only

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
Do Not Use
  • if this product changes color
  • if you are sensitive to any ingredient in this product
Questions?

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

www.systane.com

[email protected]

Other Information
  • store at room temperature
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.

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.

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

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

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

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 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
Section 55105-1 (55105-1)
Active Ingredients Purpose
Propylene Glycol 0.6% Lubricant
Warnings

For external use only

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

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

www.systane.com

[email protected]

Other Information (Other information)
  • store at room temperature
Directions for Use: (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.

Inactive Ingredients (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.

Principal Display Panel (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

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
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.

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

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