FDA.reportPublic FDA data

Systane Pro PF - Alcon Laboratories, Inc. | Kaysersberg Pharmaceuticals

Manufacturer
Alcon Laboratories, Inc. | Kaysersberg Pharmaceuticals
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:57:13

Label at a glance#

ProductSystane Pro PF
Active ingredientPropylene Glycol
Label structure12 sections

Indications and 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

Dosage and administration

shake well before using put 1 or 2 drops in the affected eye(s) as needed

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Propylene Glycol 0.6%Lubricant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if this product changes color
  • if you are sensitive to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • do not reuse
  • once opened, discard

Stop use and ask a doctor if you experience any of the following:

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed

Other information

OTHER SAFETY INFORMATION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

In the U.S. call 1-800-757-9195
www.systane.com
alcon.medinfo@alcon.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Preservative-Free

Systane® LUBRICANT EYE DROPS

PRO PF
TRIPLE ACTION
DRY EYE RELIEF

Hydrates, Restores, Protects
Long-Lasting
With Hyaluronate

Convenient Single Vials On-the-Go

Up to 12 HR RELIEF

#1 DOCTOR RECOMMENDED BRANDS1

Alcon
Sterile 32 Vials 0.5mL (0.01 fl oz) each

Side Panel:

Systane® LUBRICANT EYE DROPS 

PRO PF
TRIPLE ACTION
DRY EYE RELIEF

Convenient Single Vials On-the-Go

Directions: Make sure container is intact before use. To open, COMPLETELY TWIST OFF
TAB.
Do not pull off. Put 1 or 2 drops in the affected eye(s) as needed.
Throw away container. Do not reuse.
TAMPER EVIDENT: For your protection, do not use if vial is damaged or opened.

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

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

U.S. Pat.: www.alconpatents.com
Made in France

441240-0725

Carton Label 32 Count
Carton Label 32 Count

Sample – Not for Sale

Systane® LUBRICANT EYE DROPS

PRO PF
TRIPLE ACTION
DRY EYE RELIEF

Hydrates, Restores, Protects
Long-Lasting
With Hyaluronate

up to 12 HR RELIEF

#1 DOCTOR RECOMMENDED BRANDS1

Alcon

Sterile
5 Vials 0.5mL (0.01 FL OZ)

Side Panel:

Exclusive Formula Not Found in Store Brands

Directions: Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB.
Do not pull off. Put 1 or 2 drops in the affected eye(s) as needed.
Throw away container. Do not reuse.
TAMPER EVIDENT: For your protection, do not use if vial is damaged or opened.

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

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Made in France
U.S. Pat.: www.alconpatents.com

440221

Carton
Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2265162propylene glycol 0.6 % Ophthalmic SuspensionPSN4
2265162propylene glycol 6 MG/ML Ophthalmic SuspensionSCD4
2265162propylene glycol 0.6 % Ophthalmic SuspensionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-9308-05Systane Pro PF5 in 1 CARTONEMULSION54
0065-9308-05Systane Pro PF0.5 mL in 1 VIAL, SINGLE-DOSEEMULSION0.54
0065-9308-06Systane Pro PF0.5 mL in 1 VIAL, SINGLE-DOSEEMULSION0.54
0065-9308-06Systane Pro PF32 in 1 CARTONEMULSION324

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0065-93080065-9308-05, 0065-9308-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Propylene Glycol6DC9Q167V3ACTIB
Boric AcidR57ZHV85D4IACT
Dimyristoylphosphatidylglycerol, Dl-BI71WT9P3RIACT
Guaraprolose (3500 Mpa.S At 1%)3A1I7376TCIACT
Mineral OilT5L8T28FGPIACT
Polyoxyl 40 Stearate Type I13A4J4NH9IIACT
Hyaluronate SodiumYSE9PPT4THIACT
Sorbitan Tristearate6LUM696811IACT
Sorbitol506T60A25RIACT
Water059QF0KO0RIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-01-14monthly-update2026-06-03 17:52:52

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
ndc (package): 0065-9308-05
ndc (package): 0065-9308-06
ndc (product): 0065-9308
ndc11 (package): 00065930805
ndc11 (package): 00065930806
spl id: 504aba5a-b1fc-4d22-868e-d1a3ac351a24
spl set id: a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.