FDA.reportPublic FDA data

Systane Pro PF - Alcon Laboratories, Inc. | Alcon Research LLC

Manufacturer
Alcon Laboratories, Inc. | Alcon Research LLC
Effective date
2026-08-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-08-13 01:01:06

Label at a glance#

ProductSystane Pro PF
Active ingredientPropylene Glycol
Label structure15 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 see side of carton for directions for use

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
  • replace cap after each use

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
  • see side of carton for directions for use

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

Directions for use:

DOSAGE & ADMINISTRATION SECTION

  • 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).
    ShakeShake
  • 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

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

up to 12 HR RELIEF

#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

300073054-0825

1 bottle carton
1 bottle carton

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

2 Bottle Carton
2 Bottle Carton

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Bottle
Bottle

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-3290-03ML - Milliliter0065-32909c82314d-dae9-4aa7-933e-6028a27b219f12025-03-04
0065-3290-05ML - Milliliter0065-32900f4fd2bf-1b10-41ce-bdaf-0a3441b24a8212025-03-04

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
0065-32900065-3290-03, 0065-3290-05, 0065-3290-72

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
42026-05-12full-release2026-06-01 01:57:08

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.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
ndc (package): 0065-3290-05
ndc (package): 0065-3290-72
ndc (package): 0065-3290-03
ndc (product): 0065-3290
ndc11 (package): 00065329005
ndc11 (package): 00065329072
ndc11 (package): 00065329003
spl id: d9ca8c34-79fe-4faf-8760-3a2ed1285d93
spl set id: 23b3515f-fbe5-4398-b2df-8b2eccdd01e2

Reported adverse events (FAERS/openFDA)#

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