FDA.reportPublic FDA data

Systane Day and Night Value Pack

Manufacturer
Alcon Laboratories, Inc. | Alcon Research LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:04:42

Label at a glance#

ProductSystane Day and Night Value Pack
Active ingredientPolyethylene Glycol 400, Propylene Glycol
Label structure23 sections

Indications and uses

temporary relief of burning and irritation due to dryness of the eye temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun

Dosage and administration

shake well before using put 1 or 2 drops in the affected eye(s) as needed

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

SYSTANE® ULTRA Lubricant Eye Drops

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of burning and irritation due to dryness of the eye
  • temporarily relieves discomfort due to minor irritations 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
  • 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

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients

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.

Questions?

OTC - QUESTIONS SECTION

In the U.S. call 1-800-757-9195
alcon.medinfo@alcon.com
www.systane.com

SYSTANE® GEL DROPS Lubricant Eye Gel

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of burning and irritation due to dryness of the eye
  • temporarily relieves discomfort due to minor irritations 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
  • 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

STORAGE AND HANDLING SECTION

  • 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 toll free 1-800-757-9195 
alcon.medinfo@alcon.com
www.systane.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAY & NIGHT VALUE PACK

Systane®

ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMING DRY EYE RELIEF

DAYTIME

Fast-acting hydration and lasting relief
Moisture-rich formula

#1 DOCTOR RECOMMENDED BRAND1

GEL DROPS
LUBRICANT EYE GEL

SOOTHING DRY EYE RELIEF

NIGHTTIME

Long-lasting formula
Day or night protection

LIQUID GEL

STERILE

Two 10 mL Bottles (1/3 FL OZ EACH)

Alcon®

This Value Pack
gives you fast-acting
hydration and
long-lasting relief,
for day or night
protection.

ACTUAL SIZE BOTTLES

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

www.alconpatents.com

ALCON LABORATORIES, INC.
Fort Worth, TX 76134 USA 

Made in USA from domestic and
foreign materials

300048647-0621
 
LOT:
EXP.:

Carton
Carton

Systane® ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE

STERILE
10 mL (1/3 FL OZ)

FOR EXTERNAL USE ONLY.

INDICATIONS: For the temporary relief of burning and irritation due to dryness of the eye.

DIRECTIONS: Shake well and instill 1 or 2 drops in the affected eye(s) as needed.

WARNINGS: See carton for WARNINGS.

INGREDIENTS:

Actives: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%.

Inactives: 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.

Store at room temperature. 

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

Alcon®

LOT:

EXP.:

300055616-1221

Ultra DayNight bottle label
Ultra DayNight bottle label

Systane® GEL DROPS
LUBRICANT EYE GEL

Soothing Dry Eye Relief

STERILE
10 mL (1/3 FL OZ)

FOR EXTERNAL USE ONLY.

Uses: See carton for USES.

WARNINGS: See carton for WARNINGS.

Directions: Shake well and put 1 or 2 drops in the affected eye(s) as needed.  

INGREDIENTS:

Actives: Polyethylene Glycol 0.4% and Propylene Glycol 0.3%.

Inactives: 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.
Store at room temperature. 

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

LOT:
EXP.:

300048641-0621

Bottle Label
Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1989901{1 (10 ML) (polyethylene glycol 400 0.004 MG/MG / propylene glycol 0.003 MG/MG Ophthalmic Gel) / 1 (10 ML) (polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic Solution) } PackGPCK9
895753polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic GelPSN9
1989901polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic Gel (10 mL) / polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic Solution (10 mL) PackPSN9
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN9
895753polyethylene glycol 400 0.004 MG/MG / propylene glycol 0.003 MG/MG Ophthalmic GelSCD9
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD9
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY9
895753polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic GelSY9

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
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-1502-10Systane Day and Night Value Pack1 in 1 CARTONKIT19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-1502SYSTANE DAY AND NIGHT VALUE PACK (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%) KIT [ALCON LABORATORIES, INC.]9Current NDC, Legacy NDC, 1 package rows20231216_df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-1502-10ML - Milliliter0065-1502d1ec4238-951f-47f8-8c0d-6a5e7a92057712022-06-06

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0065-15020065-1502-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Polyethylene Glycol 400B697894SGQACTIB
Propylene Glycol6DC9Q167V3ACTIB
AminomethylpropanolLU49E6626QIACT
Boric AcidR57ZHV85D4IACT
Guar GumE89I1637KEIACT
Polidronium Chloride6716Z5YR3GIACT
Potassium Chloride660YQ98I10IACT
Water059QF0KO0RIACT
Sodium Chloride451W47IQ8XIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT
Polyethylene Glycol 400B697894SGQACTIB
Propylene Glycol6DC9Q167V3ACTIB
AminomethylpropanolLU49E6626QIACT
Boric AcidR57ZHV85D4IACT
Edetate Disodium7FLD91C86KIACT
Guar GumE89I1637KEIACT
Polidronium Chloride6716Z5YR3GIACT
Potassium Chloride660YQ98I10IACT
Sodium Chloride451W47IQ8XIACT
Sorbitol506T60A25RIACT
Water059QF0KO0RIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT

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 Day and Night Value PackPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%Alcon Laboratories, Inc.df13ca6f-7ce1-455a-ae13-9bbc5e9d2e072023-12-15WarningsExact identifier
ndc (package): 0065-1502-10
ndc (product): 0065-1502
ndc11 (package): 00065150210
spl id: 90134f50-ea64-4651-a2c0-afa48e09f129
spl set id: df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07

Reported adverse events (FAERS/openFDA)#

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