Freshkote Preservative Free Lubricant Eye Drops

Manufacturer
Excelvision
Effective date
2021-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:47:36

Label at a glance#

ProductFreshkote Preservative Free Lubricant Eye Drops
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE
Label structure9 sections

Indications and uses

For use as a lubricant to reduce further irritation or to relieve dryness of the eye For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Dosage and administration

Instill 1 drop in the affected eye(s) as needed.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl alcohol 2.7%

Povidone 2.0%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • For use as a lubricant to reduce further irritation or to relieve dryness of the eye
  • For the temporary relief of 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 if

OTC - DO NOT USE SECTION

  • Solution changes color or becomes cloudy
  • You are sensitive to any ingredient in this product 
  • Tab on vial is torn, broken, or missing

When using this product

OTC - WHEN USING SECTION

  • Do not touch tip of container to any surface to avoid contamination 
  • Do not reuse
  • Once opened, discard

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • You experience eye pain
  • You experience changes in vision 
  • You experience continued redness or irritation 
  • Condition worsens 
  • Symptoms last more than 72 hors

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

Instill 1 drop in the affected eye(s) as needed.

Other information

SPL UNCLASSIFIED SECTION

  • Use before expiration date marked on container
  • Store at 20-25°C (68-77°F)
  • Retain this carton for future referece 
  • Do not freeze

Inactive ingredinets

INACTIVE INGREDIENT SECTION

Boric acid, Edetate disodium, Ethanol, Glycerin, Phospholipids, Polysorbate 80, Potassium chloride, Purified water, Sodium chloride, May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-844-390-0720

Package Labeling:81372-002-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer.PackageOuter.PackageInner.PackageInner.Package

Package Labeling:81372-002-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81372-00281372-002-01, 81372-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
bf8f89d0-0c43-542f-e053-2995a90a3deee6b73558-ea08-44b1-a616-421d9f8423e32021-04-09WarningsExact identifier
spl id: bf8f89d0-0c43-542f-e053-2995a90a3dee
spl set id: e6b73558-ea08-44b1-a616-421d9f8423e3

Reported adverse events (FAERS/openFDA)#

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