Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 798ffdde-1dba-4a3f-a0b6-937f9e958cca
Route
OPHTHALMIC
Published
Effective Date 2025-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Propylene Glycol (.06 mg)
Inactive Ingredients
Boric Acid Dimyristoylphosphatidylglycerol, Dl- Guaraprolose (3500 Mpa.s At 1%) Mineral Oil Polyoxyl 40 Stearate Type I Sorbitan Tristearate Sorbitol Water Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

Active Ingredients Purpose Propylene Glycol 0.06% Lubricant


Medication Information

Description

Active Ingredients Purpose Propylene Glycol 0.06% 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 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
Propylene Glycol 0.06% 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]

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.
  • Replace cap after use.
  • Discard 90 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.

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

Other Information
  • store at room temperature
Inactive Ingredients

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

Principal Display Panel

3 PACK



Preservative-Free



SYSTANE ®  LUBRICANT EYE DROPS



COMPLETE PF

MULTI-SYMPTON

DRY EYE RELIEF



All-in-One Formula



Tear evaporation protection



Preservative-Free Bottles



#1 Doctor Recommended Brands1



Alcon



Sterile

Three 10mL (0.34 FL OZ) Bottles



LOT:                                         EXP:



Side Panel:

Preservative-Free



Multi-Symptom



Relief for



Sensitive eyes



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Country of Origin: United States

U.S. Patent: www.alconpatents.com



Actual Size



300073255-0725

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.


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 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
Propylene Glycol 0.06% 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]

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.
  • Replace cap after use.
  • Discard 90 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.

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

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

3 PACK



Preservative-Free



SYSTANE ®  LUBRICANT EYE DROPS



COMPLETE PF

MULTI-SYMPTON

DRY EYE RELIEF



All-in-One Formula



Tear evaporation protection



Preservative-Free Bottles



#1 Doctor Recommended Brands1



Alcon



Sterile

Three 10mL (0.34 FL OZ) Bottles



LOT:                                         EXP:



Side Panel:

Preservative-Free



Multi-Symptom



Relief for



Sensitive eyes



Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Country of Origin: United States

U.S. Patent: www.alconpatents.com



Actual Size



300073255-0725

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.


Advanced Ingredient Data


Raw Label Data

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