FDA.reportPublic FDA data

Systane Ultra Single Eye Drops 0.4 ml 16843ZZ (2018)

Manufacturer
United Exchange Corp.
Effective date
2018-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:14

Label at a glance#

ProductSystane Ultra Single Vials
Active ingredientPROPYLENE GLYCOL, POLYETHYLENE GLYCOL 400
Label structure12 sections

Storage and handling

Other information store at room temperature

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Polyethylene glycol 400 0.4%..............................Lubricant

Propylene glycol 0.3%.........................................Lubricant

OTC - PURPOSE SECTION

Use

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

WARNINGS SECTION

Warnings

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
  • do not reuse
  • once opened, discard

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 last 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

INDICATIONS & USAGE SECTION

Directions

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

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

aminomethylpropanol, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, sodium hydroxide, sorbitol, water for injection

DOSAGE & ADMINISTRATION SECTION

Made in South Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

singlesingle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN1
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD1
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65923-843-042020-01-31C16284748780-19d75b9d0-ed07-f424-e053-dadaa90a57ceSystane Ultra Single Eye Drops 0.4 ml 16843ZZ (2018)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-843-04Systane Ultra Single Vials0.4 mL in 1 VIALSOLUTION/ DROPS0.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-843SYSTANE ULTRA SINGLE VIALS (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]1Legacy NDC, 1 package rows20180125_638a4320-9c1a-4122-e053-2991aa0af758.zip

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
65923-84365923-843-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB
HYDROXYETHYL CELLULOSE (1800 MPA.S AT 2%)6OX6A5C7B6IACT
SODIUM CHLORIDE451W47IQ8XIACT
SORBITOL506T60A25RIACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYETHYLENE GLYCOL 400B697894SGQACTIB
HYDROCHLORIC ACIDQTT17582CBIACT
POTASSIUM CHLORIDE660YQ98I10IACT

Source Document#

Source XML · Source PDF

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
638a4320-9c1b-4122-e053-2991aa0af758638a4320-9c1a-4122-e053-2991aa0af7582018-01-24WarningsExact identifier
spl id: 638a4320-9c1b-4122-e053-2991aa0af758
spl set id: 638a4320-9c1a-4122-e053-2991aa0af758

Reported adverse events (FAERS/openFDA)#

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