FDA.reportPublic FDA data

REFRESH Classic

Manufacturer
A-S Medication Solutions
Effective date
2024-03-14
Label type
HUMAN OTC DRUG LABEL
Version
18
Source
full-release
Hydrated at
2026-06-01 00:09:48

Label at a glance#

ProductREFRESH CLASSIC
Active ingredientPOLYVINYL ALCOHOL, POVIDONE
Label structure10 sections

Indications and uses

For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.

Dosage and administration

To open, TWIST AND PULL TAB TO REMOVE . Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl Alcohol 1.4%

Povidone 0.6%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • May be used as a protectant against further irritation.

Warnings

WARNINGS SECTION

  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.
  • Do not touch unit-dose tip to eye.
  • If solution changes color or becomes cloudy, do not use.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

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

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Other information

OTHER SAFETY INFORMATION

  • Use only if single-use container is intact.
  • Use before expiration date marked on container.
  • Store at 59°-77°F (15°-25°C).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions or comments?

OTC - QUESTIONS SECTION

1.800.678.1605

refreshbrand.com

v1.0DFL0506

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-2358

NDC: 50090-2358-1 .4 mL in a VIAL, SINGLE-USE / 30 in a CARTON

Polyvinyl Alcohol, Povidone

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359969polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic SolutionPSN18
359969polyvinyl alcohol 0.014 ML/ML / povidone 6 MG/ML Ophthalmic SolutionSCD18
359969polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic SolutionSY18

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2358-12023-02-07C16284748780-1f386c64a-03fc-0266-e053-dadaa90a7c1aREFRESH CLASSIC
50090-2358-12023-01-30C16284748780-1f386c64a-03fc-0266-e053-dadaa90a7c1aREFRESH CLASSIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2358-1REFRESH CLASSIC30 in 1 CARTONSOLUTION/ DROPS3018
50090-2358-1REFRESH CLASSIC.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS.418

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2358REFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 2 package rows20240316_3bf6193c-56db-45ad-844c-58eb8c33cba9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2358-1EA - Each50090-2358d52774bd-6c4e-4090-870a-10d4222167c412019-02-13
0023-0506-01EA - Each0023-05066f103f52-b51b-4112-8b6f-0dbff9ac462a12012-07-24
0023-0506-50EA - Each0023-0506d349c8e5-b120-43bc-a75d-eb0c165a554e12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-235850090-2358-1
0023-0506

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL532B59J990ACTIB
POVIDONEFZ989GH94EACTIB
water059QF0KO0RIACT
sodium chloride451W47IQ8XIACT
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
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
ndc (package): 50090-2358-1
ndc (product): 50090-2358
ndc11 (package): 50090235801
spl id: 2a6ae637-2f65-4a5f-99d3-e3560f67b8f0
spl set id: 3bf6193c-56db-45ad-844c-58eb8c33cba9

Reported adverse events (FAERS/openFDA)#

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