FDA.reportPublic FDA data

SYSTANE HYDRATION PF PRESERVATIVE FREE

Manufacturer
Alcon Laboratories, Inc. | Kaysersberg Pharmaceuticals
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:04:42

Label at a glance#

ProductSYSTANE HYDRATION PF PRESERVATIVE FREE
Active ingredientPolyethylene Glycol 400, Propylene Glycol
Label structure12 sections

Indications and uses

for use as a protectant against further irritation or to relieve dryness of the eye

Dosage and administration

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
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Uses

INDICATIONS & USAGE SECTION

  • for use as a protectant against 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 or becomes cloudy
  • 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

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

  • 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

aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate, 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
www.systane.com
alcon.medinfo@alcon.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SYSTANE®
Lubricant Eye Drops

HYDRATION PF
PRESERVATIVE-FREE
DRY EYE RELIEF

Convenient
Single Vials
On-the-Go

Extra moisturizing for sensitive eyes

Longer lasting hydration*

VOTED PRODUCT OF THE YEAR
Consumer Survey of Product Innovation
2021±

Hydro
Boost
TECHNOLOGY

Alcon

STERILE
30 Vials 0.7 mL (0.02 FL OZ)

Experience
preservative-free
relief that’s extra
moisturizing for
sensitive eyes 

Common Dry Eye Symptoms
• Burning or stinging
• Fluctuating vision
• Irritation
• Watery eyes

TAMPER EVIDENT:
For your protection, do not use if vial is damaged or opened at time of purchase.

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

* vs SYSTANE® ULTRA Lubricant Eye Drops

±Winner Eye Care Category. Survey of 40,000
people by Kantar.

www.alconpatents.com
Made in France 

436272-0221

SYSTANE® Lubricant Eye Drops

HYDRATION PF
PRESERVATIVE-FREE
DRY EYE RELIEF

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. 

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

LOT:
EXP.: 

Front Label
Front Label
Back Label
Back Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN7
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD7
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY7

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
0065-1437-04SYSTANE HYDRATION PF PRESERVATIVE FREE30 in 1 CARTONSOLUTION/ DROPS307
0065-1437-04SYSTANE HYDRATION PF PRESERVATIVE FREE0.7 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS0.77
0065-1437-05SYSTANE HYDRATION PF PRESERVATIVE FREE0.7 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS0.77
0065-1437-05SYSTANE HYDRATION PF PRESERVATIVE FREE5 in 1 CARTONSOLUTION/ DROPS57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-1437SYSTANE HYDRATION PF PRESERVATIVE FREE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]7Current NDC, Legacy NDC, 4 package rows20231216_db3a6c68-320b-46b0-83fa-6c29297a84a6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-1437-04EA - Each0065-1437437fdd7b-8ec0-4607-9d25-2b04d3bc016f12020-05-08

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0065-14370065-1437-04, 0065-1437-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 Borate91MBZ8H3QOIACT
Sodium Chloride451W47IQ8XIACT
Hyaluronate SodiumYSE9PPT4THIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT
Sorbitol506T60A25RIACT

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 HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.db3a6c68-320b-46b0-83fa-6c29297a84a62023-12-15WarningsExact identifier
ndc (package): 0065-1437-04
ndc (package): 0065-1437-05
ndc (product): 0065-1437
ndc11 (package): 00065143704
ndc11 (package): 00065143705
spl id: 1eb226c4-8b11-4a92-ab95-5333e866ba13
spl set id: db3a6c68-320b-46b0-83fa-6c29297a84a6

Reported adverse events (FAERS/openFDA)#

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