FDA.reportPublic FDA data

ImproVue ® Ophthalmic Lubricant Drops

Manufacturer
Oculus Surgical, Inc. | OASIS Medical, Inc.
Effective date
2025-01-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:53:28

Label at a glance#

ProductImproVue Lubricant
Active ingredientHYPROMELLOSE 2208 (15000 MPA.S)
Label structure10 sections

Dosage and administration

Remove cap from syringe and screw on applicator tip. Instill 1 or 2 drops in the affected eye(s) as needed.

Storage and handling

Do not use if pouch is damaged or has been previously opened. Protect from freezing Store at or below 25°C (77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hypromellose (1.7%)

Purpose

OTC - PURPOSE SECTION

Ophthalmic Lubricant

Indications

INDICATIONS & USAGE SECTION

  • For the temporary relief of burning and irritation due to 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.
  • To avoid contamination do not touch tip of container or applicator to any surface.
  • Do not reuse. Once opened, discard.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.
  • If solution changes color or becomes cloudy, do not use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Remove cap from syringe and screw on applicator tip.
  • Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

STORAGE AND HANDLING SECTION

  • Do not use if pouch is damaged or has been previously opened.
  • Protect from freezing
  • Store at or below 25°C (77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calcium chloride dihydrate, hydrochloric acid1, magnesium chloride hexahydrate, potassium chloride, purified water, sodium acetate trihydrate, sodium chloride, sodium citrate dihydrate, and sodium hydroxide1

1 May contain one or more of these ingredients for pH adjustment

Questions or Comments?

OTC - QUESTIONS SECTION

(855) 734-2466 or (772) 236-2622 or log onto www.oculussurgical.com

PRINCIPAL DISPLAY PANEL - 6 Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ImproVue®

Ophthalmic Lubricant Drops

  • Sterile
  • Preservative-free
  • Single use, disposable container

Contains:

6 Pouches, each Pouch containing
1 Single Use Syringe, 0.07 fl oz (2 ml)
1 Single Use Applicator Tip

OCULUS®
SURGICAL
www.oculussurgical.com

Principal Display Panel - 6 Pouch Carton
Principal Display Panel - 6 Pouch Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1540361hypromellose 1.7 % Ophthalmic SolutionPSN5
1540361hypromellose 17 MG/ML Ophthalmic SolutionSCD5
1540361hypromellose 1.7 % Ophthalmic SolutionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62144-5510-5ImproVueLubricant6 in 1 CARTONSOLUTION/ DROPS65
62144-5510-5ImproVueLubricant1 in 1 POUCHSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62144-5510IMPROVUE LUBRICANT (HYPROMELLOSE 2208 (15000 MPA.S)) SOLUTION/ DROPS [OCULUS SURGICAL, INC.]5Current NDC, Legacy NDC, 2 package rows20250124_63b82129-4848-47c5-bf92-ec4b1a9e9974.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62144-5510-5ML - Milliliter62144-551058aea7da-9ad9-4a80-b951-b0aad85e1fd712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYPROMELLOSE 2208 (15000 MPA.S)ACTIVE INGREDIENTZ78RG6M2N21
HYPROMELLOSE 2208 (15000 MPA.S)ACTIVE MOIETYZ78RG6M2N21
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5M1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB1
Magnesium ChlorideINACTIVE INGREDIENT02F3473H9O1
Potassium ChlorideINACTIVE INGREDIENT660YQ98I101
Sodium AcetateINACTIVE INGREDIENT4550K0SC9B1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95K1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62144-551062144-5510-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2ACTIB
CALCIUM CHLORIDEM4I0D6VV5MIACT
HYDROCHLORIC ACIDQTT17582CBIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM ACETATE4550K0SC9BIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
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 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium AcetateSODIUM ACETATE4550K0SC9BSOLUTION/ DROPS / OPHTHALMIC1.24 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Calcium ChlorideCALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Magnesium ChlorideMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact 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
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Calcium ChlorideCALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium AcetateSODIUM ACETATE4550K0SC9BSOLUTION/ DROPS / OPHTHALMIC1.24 %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
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
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Magnesium ChlorideMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Trisodium Citrate DihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION/ DROPS / OPHTHALMIC1 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
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Trisodium Citrate DihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION/ DROPS / OPHTHALMIC1 mgExact 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ImproVue LubricantHYPROMELLOSE 2208 (15000 MPA.S)Oculus Surgical, Inc.63b82129-4848-47c5-bf92-ec4b1a9e99742025-01-22WarningsExact identifier
ndc (package): 62144-5510-5
ndc (product): 62144-5510
ndc11 (package): 62144551005
spl id: 8d8a7585-2067-470f-912c-e62ab6277ec2
spl set id: 63b82129-4848-47c5-bf92-ec4b1a9e9974

Reported adverse events (FAERS/openFDA)#

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