FDA.reportPublic FDA data

Polyvinyl Alcohol Ophthalmic Solution

Manufacturer
AvPAK
Effective date
2026-07-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
weekly-update
Hydrated at
2026-07-17 21:43:43

Label at a glance#

ProductPolyvinyl Alcohol
Active ingredientPOLYVINYL ALCOHOL
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

Shake well before use instill 1 to 2 drops in the affected eye(s) as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl Alcohol 1.4%

Purpose

OTC - PURPOSE SECTION

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

  • Do not use if solution changes color or becomes cloudy

 

When using this product

SPL UNCLASSIFIED SECTION

  • Avoid contamination, do not touch tip of container to any surface.
  • Replace cap after use

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • 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 (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use
  • instill 1 to 2 drops in the affected eye(s) as needed

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature 15-30C (59-86F)
  • Do No Use if imprinted seal on cap is torn, broken or missing
  • Discard 90 days after opening
  • Retain outer carton for full product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%

Questions ?

OTC - QUESTIONS SECTION

Call 1-855-361-3993

Distributed by:

AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-678-15ML - Milliliter50268-678539307a9-64ef-4538-be7e-fdd8ceeacac912023-02-06

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50268-67850268-678-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
POLYVINYL ALCOHOL532B59J990ACTIB
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-04-21full-release2026-06-01 00:59:29

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
Polyvinyl AlcoholPOLYVINYL ALCOHOLAvPAKf18b61da-4033-341a-e053-2a95a90a8ebf2026-07-07WarningsExact identifier
ndc (package): 50268-678-15
ndc (product): 50268-678
ndc11 (package): 50268067815
spl id: 5606ef6c-2a66-67dd-e063-6294a90a9934
spl set id: f18b61da-4033-341a-e053-2a95a90a8ebf

Reported adverse events (FAERS/openFDA)#

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