Systane

Manufacturer
Alcon Laboratories, Inc. | Kaysersberg Pharmaceuticals | Laboratoire Unither
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 00:04:39

Label at a glance#

ProductSystane ULTRA
Active ingredientPolyethylene Glycol 400, PROPYLENE GLYCOL
Label structure8 sections

Indications and uses

For the temporary relief of burning and irritation due to dryness of the eye for temporary relief of discomfort due to minor irritation of the eye or to exposure to wind or sun

Dosage and administration

Put 1 or 2 drops in the affected eye(s) as needed.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of burning and irritation due to dryness of the eye
  • for temporary relief of discomfort due to minor irritation 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 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
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

SPL UNCLASSIFIED SECTION

  • 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
www.systane.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Systane®
LUBRICANT EYE DROPS    

ULTRA PF


PRESERVATIVE-FREE
DRY EYE RELIEF

Convenient Single Vials On-The-Go

Great for sensitive eyes

Fast-acting hydration
and lasting relief

Moisture-rich formula

#1 Doctor Recommended Brand1

STERILE
60 Vials 0.7 mL Each

Alcon

SIDE DISPLAY PANEL

Systane®
LUBRICANT EYE DROPS

ULTRA PF

PRESERVATIVE-FREE
DRY EYE RELIEF

Convenient Single Vials On-The-Go

Open your eyes to a
breakthrough in comfort with
SYSTANE® ULTRA Lubricant Eye Drops.

SYSTANE® ULTRA preservative-free vials
elevates the science of dry eye therapy
to a new level so you can have relief
from dry eye anytime, anywhere.

From first blink eyes feel lubricated
and refreshed.

Feel the difference in dry eye relief
with SYSTANE ® ULTRA

TAMPER EVIDENT:
Do not use if vial is damaged or opened at time of purchase.

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

www.alconpatents.com
Made in France

W435221-0919

Carton Label
Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN15
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD15
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY15

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
0065-1432-01SystaneULTRA24 in 1 CARTONSOLUTION/ DROPS2415
0065-1432-01SystaneULTRA0.4 mL in 1 VIALSOLUTION/ DROPS0.415
0065-1432-02SystaneULTRA4 in 1 CARTONSOLUTION/ DROPS415
0065-1432-02SystaneULTRA0.4 mL in 1 VIALSOLUTION/ DROPS0.415
0065-1432-03SystaneULTRA0.4 mL in 1 VIALSOLUTION/ DROPS0.415
0065-1432-03SystaneULTRA72 in 1 CARTONSOLUTION/ DROPS7215
0065-1432-04SystaneULTRA5 in 1 CARTONSOLUTION/ DROPS515
0065-1432-04SystaneULTRA.7 mL in 1 VIALSOLUTION/ DROPS.715
0065-1432-05SystaneULTRA.7 mL in 1 VIALSOLUTION/ DROPS.715
0065-1432-05SystaneULTRA60 in 1 CARTONSOLUTION/ DROPS6015
0065-1432-06SystaneULTRA.7 mL in 1 VIALSOLUTION/ DROPS.715
0065-1432-06SystaneULTRA25 in 1 CARTONSOLUTION/ DROPS2515

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-1432SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]15Current NDC, Legacy NDC, 12 package rows20231216_a5c1c194-3db5-4f18-9cd1-97f7f84c3cff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-1432-01EA - Each0065-143214f1c113-d43c-471c-89e7-cad2980b32cd12012-07-24
0065-1432-05EA - Each0065-1432417bc31a-48fa-44c1-8b41-76c88a58e78212018-08-13
0065-1432-06EA - Each0065-1432c4bb8e26-fe99-426e-a250-b66107f54fab12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Polyethylene Glycol 400ACTIVE INGREDIENTB697894SGQ4
PROPYLENE GLYCOLACTIVE INGREDIENT6DC9Q167V34
Polyethylene GlycolsACTIVE MOIETY3WJQ0SDW1A4
PROPYLENE GLYCOLACTIVE MOIETY6DC9Q167V34
AminomethylpropanolINACTIVE INGREDIENTLU49E6626Q4
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D44
GUAR GUMINACTIVE INGREDIENTE89I1637KE4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB4
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I104
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I4
SORBITOLINACTIVE INGREDIENT506T60A25R4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0065-14320065-1432-01, 0065-1432-02, 0065-1432-03, 0065-1432-04, 0065-1432-05, 0065-1432-06

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 63 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
GUAR GUMGUAR GUME89I1637KESUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii+route
7 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GUAR GUMGUAR GUME89I1637KESUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii+route
7 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GUAR GUMGUAR GUME89I1637KESUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii+route
7 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
GUAR GUMGUAR GUME89I1637KESUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii+route
7 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GUAR GUMGUAR GUME89I1637KESUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii+route
7 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GUAR GUMGUAR GUME89I1637KESUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii+route
7 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
GUAR GUMGUAR GUME89I1637KESUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii+route
7 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
7 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
7 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
14 equally ranked IID candidates

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 ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
ndc (package): 0065-1432-06
ndc (package): 0065-1432-05
ndc (package): 0065-1432-04
ndc (package): 0065-1432-01
ndc (package): 0065-1432-03
ndc (package): 0065-1432-02
ndc (product): 0065-1432
ndc11 (package): 00065143202
ndc11 (package): 00065143205
ndc11 (package): 00065143204
ndc11 (package): 00065143201
ndc11 (package): 00065143206
ndc11 (package): 00065143203
spl id: cce3e663-58ef-4ece-a6d2-c49ecc7ea9cb
spl set id: a5c1c194-3db5-4f18-9cd1-97f7f84c3cff

Reported adverse events (FAERS/openFDA)#

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