FDA.reportPublic FDA data

Systane Gel Drops Drug Facts

Manufacturer
Alcon Laboratories, Inc. | Alcon Research LLC | Alcon Singapore Manufacturing Pte. Ltd.
Effective date
2025-07-30
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:08:55

Label at a glance#

ProductSystane
Active ingredientPolyethylene Glycol 400, Propylene Glycol
Label structure12 sections

Indications and uses

for the temporary relief of burning and irritation due to dryness of the eye for use as a protectant against 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
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 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
  • 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

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

  • 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

aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, 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
alcon.medinfo@alcon.com
www.systane.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Systane®
LUBRICANT EYE GEL

GEL DROPS
SOOTHING DRY EYE RELIEF

Long-lasting formula
Day or night protection

#1 DOCTOR RECOMMENDED BRAND1
LIQUID GEL

STERILE
10mL (1/3 FL OZ)

Alcon

SIDE PANEL

TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

www.alconpatents.com

Made in USA from domestic and imported materials

Indulge your eyes in this easy-to-use droppable gel. Systane® GEL DROPS forms a protective shield over your eyes to provide enduring relief day or night.

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

300048642-0621

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

Carton
Carton

Systane®
LUBRICANT EYE GEL

GEL DROPS
SOOTHING DRY EYE RELIEF

Long-lasting formula
Day or night protection

#1 DOCTOR RECOMMENDED BRANDS1
LIQUID GEL

STERILE
10mL (1/3 fl oz)

Alcon

SIDE PANEL

TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

www.alconpatents.com

Country of Origin: Singapore

Indulge your eyes in this easy-to-use droppable gel. Systane® GEL DROPS forms a protective shield over your eyes to provide enduring relief day or night.

ACTUAL SIZE

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

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

300072079-0525

Carton
Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
895753polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic GelPSN11
895753polyethylene glycol 400 0.004 MG/MG / propylene glycol 0.003 MG/MG Ophthalmic GelSCD11
895753polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic GelSY11

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
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product 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
0065-0454-07Systane10 mL in 1 BOTTLE, DROPPERGEL1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0454-07ML - Milliliter0065-0454c92d5435-51c2-4322-bf73-999b2145c2d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Polyethylene Glycol 400ACTIVE INGREDIENTB697894SGQ2
Propylene GlycolACTIVE INGREDIENT6DC9Q167V32
Polyethylene Glycol 400ACTIVE MOIETYB697894SGQ2
Propylene GlycolACTIVE MOIETY6DC9Q167V32
AminomethylpropanolINACTIVE INGREDIENTLU49E6626Q2
Boric AcidINACTIVE INGREDIENTR57ZHV85D42
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K2
Guar GumINACTIVE INGREDIENTE89I1637KE2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB2
Polidronium ChlorideINACTIVE INGREDIENT6716Z5YR3G2
Potassium ChlorideINACTIVE INGREDIENT660YQ98I102
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I2
SorbitolINACTIVE INGREDIENT506T60A25R2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0065-04540065-0454-07

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
Edetate Disodium7FLD91C86KIACT
Guaraprolose (3500 Mpa.S At 1%)3A1I7376TCIACT
Polidronium Chloride6716Z5YR3GIACT
Potassium Chloride660YQ98I10IACT
Sodium Chloride451W47IQ8XIACT
Sorbitol506T60A25RIACT
Water059QF0KO0RIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT

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 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XGEL / OPHTHALMIC0.9 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10SUSPENSION / OPHTHALMIC0.03 %w/wExact identifier — unii+route
6 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBGEL / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route
6 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Guar GumGUAR GUME89I1637KESUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii+route
2 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION / OPHTHALMIC0.22 %w/vExact identifier — unii+route
6 equally ranked IID candidates
Polidronium ChloridePOLIDRONIUM CHLORIDE6716Z5YR3GSOLUTION / OPHTHALMICNAExact identifier — unii+route
2 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii+route
4 equally ranked IID candidates
Guar GumGUAR GUME89I1637KESUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii+route
2 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4GEL / OPHTHALMIC0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION / OPHTHALMIC0.22 %w/vExact identifier — unii+route
6 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route
4 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10SUSPENSION / OPHTHALMIC0.03 %w/wExact identifier — unii+route
6 equally ranked IID candidates
Polidronium ChloridePOLIDRONIUM CHLORIDE6716Z5YR3GSOLUTION / OPHTHALMICNAExact identifier — unii+route
2 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii+route
4 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / OPHTHALMIC6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4GEL / OPHTHALMIC0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBGEL / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route
6 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XGEL / OPHTHALMIC0.9 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / OPHTHALMIC6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route
4 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
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
ndc (package): 0065-0454-07
ndc (product): 0065-0454
ndc11 (package): 00065045407
spl id: c3c56913-9741-44fb-8f63-b355393be140
spl set id: 1d679d0f-cec2-a644-79cd-079607254bb9

Reported adverse events (FAERS/openFDA)#

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