FDA.reportPublic FDA data

Systane Ultra

Manufacturer
Alcon Laboratories, Inc.
Effective date
2011-06-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:46:31

Label at a glance#

ProductSystane Ultra
Active ingredientPolyethylene Glycol 400, Propylene Glycol
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 400 0.4%
Propylene Glycol 0.3%

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use

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

OTC - WHEN USING SECTION

When using this product

  • 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 feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

  • Shake well before using.
  • Instill 1 or 2 drops in the affected eye(s) as needed.

OTHER SAFETY INFORMATION

  • Store at room temperature.

INACTIVE INGREDIENT SECTION

Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

OTC - QUESTIONS SECTION

In the U.S. call 1-800-757-9195
 www.systane.com
 MedInfo@AlconLabs.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Systane®
ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE

EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor
Recommended
Brand1

Alcon®

STERILE
10 mL (⅓ FL OZ)

9006416-0111

Carton
Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-1431-05ML - Milliliter0065-143103bbda56-0cdc-4ff0-9e38-9d53f12f888212013-02-13
0065-1431-18ML - Milliliter0065-1431f8fa9435-ad59-4ec2-9245-e104a4a2de0012015-10-02
0065-1431-21ML - Milliliter0065-1431b445f59f-f7ae-4d04-8c41-61dd75b0567e12022-06-06
0065-1431-28ML - Milliliter0065-14313f2f93e4-b91d-4eac-9f7e-6d3e42c62a1712015-10-02
0065-1431-31ML - Milliliter0065-143193211ae7-64ee-4236-b15d-a789ac78346a12022-06-06
0065-1431-41ML - Milliliter0065-1431a7d49613-1582-40c1-a2a2-466faaf2171312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Polyethylene Glycol 400ACTIVE INGREDIENTB697894SGQ1
Propylene GlycolACTIVE INGREDIENT6DC9Q167V31
Polyethylene Glycol 400ACTIVE MOIETYB697894SGQ1
Propylene GlycolACTIVE MOIETY6DC9Q167V31
AminomethylpropanolINACTIVE INGREDIENTLU49E6626Q1
Boric AcidINACTIVE INGREDIENTR57ZHV85D41
Guar GumINACTIVE INGREDIENTE89I1637KE1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB1
Polidronium ChlorideINACTIVE INGREDIENT6716Z5YR3G1
Potassium ChlorideINACTIVE INGREDIENT660YQ98I101
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
SorbitolINACTIVE INGREDIENT506T60A25R1
WaterINACTIVE INGREDIENT059QF0KO0R1

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
0065-14310065-1431-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Polyethylene Glycol 400B697894SGQACTIB
Propylene Glycol6DC9Q167V3ACTIB
AminomethylpropanolLU49E6626QIACT
Boric AcidR57ZHV85D4IACT
Guar GumE89I1637KEIACT
Polidronium Chloride6716Z5YR3GIACT
Potassium Chloride660YQ98I10IACT
Water059QF0KO0RIACT
Sodium Chloride451W47IQ8XIACT
Sorbitol506T60A25RIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT

Source Document#

Source XML · Source PDF

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 · 20 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
Polidronium ChloridePOLIDRONIUM CHLORIDE6716Z5YR3GSOLUTION / OPHTHALMICNAExact identifier — unii+route
2 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
2 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+dosage form
2 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 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
Boric AcidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact 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
Polidronium ChloridePOLIDRONIUM CHLORIDE6716Z5YR3GSOLUTION / OPHTHALMICNAExact identifier — unii+route
2 equally ranked IID candidates
AminomethylpropanolAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
2 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
ndc (package): 0065-1431-05
ndc (product): 0065-1431
ndc11 (package): 00065143105
04158e63-bdbc-071f-1300-302b3255e94391379a76-fb7f-8357-7d75-7da54fd6d08e2011-06-21WarningsExact identifier
spl id: 04158e63-bdbc-071f-1300-302b3255e943
spl set id: 91379a76-fb7f-8357-7d75-7da54fd6d08e

Reported adverse events (FAERS/openFDA)#

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