FDA.reportPublic FDA data

Systane Ultra Preservative Free

Manufacturer
Alcon Laboratories, Inc. | Alcon Research LLC | Alcon Singapore Manufacturing Pte. Ltd.
Effective date
2025-07-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:08:56

Label at a glance#

ProductSystane Ultra Preservative Free
Active ingredientPolyethylene Glycol 400, Propylene Glycol
Label structure13 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

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 - PURPOSE SECTION

Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

When using the product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

OTC - STOP USE SECTION

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.

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

Aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

OTC - QUESTIONS SECTION

In the U.S. call 1-800-757-9195
alcon.medinfo@alcon.com
www.systane.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).
Use Diagram
Use Diagram
  • 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 above).
  • Replace cap after use.
  • Discard 90 days after opening.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Preservative-Free

Systane®
LUBRICANT EYE DROPS

ULTRA PF
FAST ACTING
DRY EYE RELIEF

Moisture Rich Formula
Instantly Hydrates

Preservative-Free Bottle

DOCTOR RECOMMENDED #1 BRANDS1

Alcon

STERILE
10 mL (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

300068254-0824

Actual Size

Carton
Carton

TWIN VALUE PACK

Preservative-Free

Systane®
LUBRICANT EYE DROPS

ULTRA PF
FAST ACTING
DRY EYE RELIEF

Moisture Rich Formula
Instantly Hydrates

Preservative-Free Bottles

DOCTOR RECOMMENDED #1 BRANDS1

Alcon
STERILE
Two 10 mL (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.

Preservative-Free
Fast Acting
Relief for
Sensitive Eyes

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

ACTUAL SIZE

300068255-0824

Carton Label
Carton Label

Preservative-Free

Systane ®
LUBRICANT EYE DROPS

ULTRA PF
FAST ACTING
DRY EYE RELIEF

Moisture Rich Formula
Instantly Hydrates

Preservative-Free Bottle

DOCTOR RECOMMENDED #1 BRANDS1

Alcon

STERILE
10 mL (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: Singapore
U.S. Pat.: www.alconpatents.com

300072082-0525 

Actual Size

Carton Label
Carton Label

Systane®
LUBRICANT EYE DROPS

ULTRA PF
FAST ACTING
DRY EYE RELIEF

10 mL (0.34 FL OZ) STERILE   

Only for use in the eye.
Store at room temperature.
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.  

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

See Carton for Directions For Use.  

Country of Origin: USA

LOT:               EXP:

300068258-0824

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN5
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD5
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-1507-82Systane Ultra Preservative Free10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105
0065-1507-82Systane Ultra Preservative Free1 in 1 CARTONSOLUTION/ DROPS15
0065-1507-92Systane Ultra Preservative Free10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105
0065-1507-92Systane Ultra Preservative Free2 in 1 CARTONSOLUTION/ DROPS25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-1507-82ML - Milliliter0065-1507383f1c31-dbed-44b7-8036-3e9615356a5912023-01-09
0065-1507-92ML - Milliliter0065-15074955e447-92a4-4200-b58c-80c7fb7cbe8812023-06-06

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
0065-15070065-1507-82, 0065-1507-92

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Polyethylene Glycol 400B697894SGQACTIB
Propylene Glycol6DC9Q167V3ACTIB
AminomethylpropanolLU49E6626QIACT
Boric AcidR57ZHV85D4IACT
Guaraprolose (3500 Mpa.S At 1%)3A1I7376TCIACT
Potassium Chloride660YQ98I10IACT
Water059QF0KO0RIACT
Sodium Chloride451W47IQ8XIACT
Sorbitol506T60A25RIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT

Source Document#

Source XML

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 Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
ndc (package): 0065-1507-92
ndc (package): 0065-1507-82
ndc (product): 0065-1507
ndc11 (package): 00065150792
ndc11 (package): 00065150782
spl id: c459712f-30d9-4084-a6ff-f157d6e604a9
spl set id: 751fb85f-6683-4b0a-a650-324d4a74c5de

Reported adverse events (FAERS/openFDA)#

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