FDA.reportPublic FDA data

Systane COMPLETE Lubricant Eye Drops Drug Facts

Manufacturer
Alcon Laboratories, Inc. | Alcon Research LLC | Alcon Singapore Manufacturing Pte. Ltd.
Effective date
2025-08-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:09:53

Label at a glance#

ProductSystane COMPLETE
Active ingredientPropylene Glycol
Label structure8 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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsPurpose
Propylene Glycol 0.6%Lubricant

OTC - PURPOSE SECTION

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

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

SPL UNCLASSIFIED SECTION

  • store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD® (polyquaternium-1) 0.001% preservative,  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
alcon.medinfo@alcon.com
www.systane.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Systane® 
LUBRICANT EYE DROPS

COMPLETE
OPTIMAL DRY EYE RELIEF

Fast-acting hydration
Tear evaporation protection
Nano-droplets for better coverage*  

#1 DOCTOR RECOMMENDED BRAND1

nano droplet  

Alcon
STERILE
10mL (1/3 FL OZ)

LOT:                    EXP.:

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.

SYSTANE®
COMPLETE

Our most advanced
formula ever!

SYSTANE®
COMPLETE
Lubricant
Eye Drops
hydrates
fast, protects
against tear
evaporation, and
helps support all layers
of the tear film.

Nano droplet technology:*

● a better delivery of the
active ingredient
● better eye coverage

ACTUAL SIZE

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76143 USA

* vs SYSTANE®  BALANCE

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

www.alconpatents.com

Made in USA from domestic and imported materials

300048645-0621

Systane Caron 300048645-0621 10mL
Systane Caron 300048645-0621 10mL

Systane® 
LUBRICANT EYE DROPS

COMPLETE

MULTI-SYMPTOM
DRY EYE RELIEF

All-in-One Formula
Tear Evaporation Protection

#1 DOCTOR RECOMMENDED BRANDS1

Alcon

STERILE
10mL (1/3 fl oz)

LOT:                    EXP.:

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.

SYSTANE®
COMPLETE

SYSTANE®
COMPLETE
Lubricant
Eye Drops
 hydrates
fast, protects
against tear
evaporation, and
helps support all layers
of the tear film.

ACTUAL SIZE

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76143 USA

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

www.alconpatents.com

Country of Origin: Singapore

300072080-0525

Carton Image
Carton Image

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0481-01Systane COMPLETE1 in 1 CARTONEMULSION110
0065-0481-01Systane COMPLETE1.5 mL in 1 BOTTLE, DROPPEREMULSION1.510
0065-0481-10Systane COMPLETE10 mL in 1 BOTTLE, DROPPEREMULSION1010
0065-0481-10Systane COMPLETE1 in 1 CARTONEMULSION110
0065-0481-11Systane COMPLETE10 mL in 1 BOTTLE, DROPPEREMULSION1010
0065-0481-11Systane COMPLETE2 in 1 CARTONEMULSION210
0065-0481-55Systane COMPLETE5 mL in 1 BOTTLE, DROPPEREMULSION510
0065-0481-55Systane COMPLETE1 in 1 CARTONEMULSION110
0065-0481-72Systane COMPLETE3 in 1 CARTONEMULSION310
0065-0481-72Systane COMPLETE10 mL in 1 BOTTLE, DROPPEREMULSION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0481-10ML - Milliliter0065-0481e390e54c-62ac-4382-978a-d1e95e645d1c12018-09-05
0065-0481-11ML - Milliliter0065-0481f2d5335f-1f79-486e-8c11-b6afe871388c12018-09-05
0065-0481-55ML - Milliliter0065-04813b95bfc8-7dd1-45b8-840d-22d8225db2cb12019-01-24

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
0065-04810065-0481-10, 0065-0481-11, 0065-0481-01, 0065-0481-55, 0065-0481-72

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
Propylene Glycol6DC9Q167V3ACTIB
Boric AcidR57ZHV85D4IACT
Dimyristoylphosphatidylglycerol, Dl-BI71WT9P3RIACT
Edetate Disodium7FLD91C86KIACT
Guar GumE89I1637KEIACT
Mineral OilT5L8T28FGPIACT
Polyoxyl 40 Stearate13A4J4NH9IIACT
Sorbitan Tristearate6LUM696811IACT
Sorbitol506T60A25RIACT
Water059QF0KO0RIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT
Polidronium Chloride6716Z5YR3GIACT

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 COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
ndc (package): 0065-0481-55
ndc (package): 0065-0481-11
ndc (package): 0065-0481-01
ndc (package): 0065-0481-10
ndc (package): 0065-0481-72
ndc (product): 0065-0481
ndc11 (package): 00065048110
ndc11 (package): 00065048101
ndc11 (package): 00065048155
ndc11 (package): 00065048172
ndc11 (package): 00065048111
spl id: 45b50f5d-7ae6-4213-a95e-cfc958755ea8
spl set id: 2df0de02-a3e2-471a-9e10-040c3fba75fe

Reported adverse events (FAERS/openFDA)#

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