FDA.reportPublic FDA data

FreshKote Preservative Free Lubricating Eye Drops Single Use

Manufacturer
FOCUS Laboratories, Inc. | ExcelVision
Effective date
2018-07-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:27

Label at a glance#

ProductFreshKote Preservative Free Lubricating Eye Drops Single Use
Active ingredientPOVIDONE, POLYVINYL ALCOHOL, UNSPECIFIED
Label structure11 sections

Storage and handling

Other information Use before expiration date marked on container Store at 20-25 ο C(68-77 ο F) Retain this carton for future reference

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients            Purpose

Polyvinyl Alcohol 2.7%.........Lubricant

Povidone 2.0%....................Lubricant

OTC - PURPOSE SECTION

Uses

  • For use as a protectant to prevent further irritation or to relieve dryness of the eye

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use if

  • Seal is damaged
  • Solution changes color or becomes cloudy
  • You are sensitive to any ingredient in this product

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • You experience eye pain
  • You experience changes in vision
  • You experience continued redness or irritation
  • Condition worsens
  • Symptoms 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.

DOSAGE & ADMINISTRATION SECTION

Directions

Instill 1 or 2 drop(s) in the affected eye(s) as needed

STORAGE AND HANDLING SECTION

Other information

  • Use before expiration date marked on container
  • Store at 20-25οC(68-77οF)
  • Retain this carton for future reference

INACTIVE INGREDIENT SECTION

Inactive ingredients

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.

INDICATIONS & USAGE SECTION

For the temporary relief of discomfort due to minor irritations of the eye or to exposure of wind or sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
630981FreshKote 2.7 % / 2 % Ophthalmic SolutionPSN2
630977polyvinyl alcohol 2.7 % / povidone 2 % Ophthalmic SolutionPSN2
630981polyvinyl alcohol 27 MG/ML / povidone 20 MG/ML Ophthalmic Solution [Freshkote]SBD2
630977polyvinyl alcohol 27 MG/ML / povidone 20 MG/ML Ophthalmic SolutionSCD2
630981Freshkote (polyvinyl alcohol 1.8 % / polyvinyl alcohol 0.9 % / povidone 2 % ) Ophthalmic SolutionSY2
630981Freshkote (polyvinyl alcohol 2.7 % / povidone 2 % ) Ophthalmic SolutionSY2
630977polyvinyl alcohol 2.7 % / povidone 2 % Ophthalmic SolutionSY2

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
15821-105-032020-01-31C16284748780-19d75b9d0-8f08-f424-e053-dadaa90a57ceFreshKote Preservative Free Lubricating Eye Drops: Single Use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15821-105-03FreshKote Preservative Free Lubricating Eye Drops Single Use5 in 1 POUCHSOLUTION52
15821-105-03FreshKote Preservative Free Lubricating Eye Drops Single Use6 in 1 BOXSOLUTION62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15821-105FRESHKOTE PRESERVATIVE FREE LUBRICATING EYE DROPS SINGLE USE (POVIDONE, POLYVINYL ALCOHOL) SOLUTION [FOCUS LABORATORIES, INC.]2Legacy NDC, 2 package rows20180726_be2f3b44-f371-4504-86d3-292cc8dfa062.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15821-10515821-105-03

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
POVIDONEFZ989GH94EACTIB
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990ACTIB
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT

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
95b926fe-97b4-4c12-814e-6a76c6ca8c23be2f3b44-f371-4504-86d3-292cc8dfa0622018-07-25WarningsExact identifier
spl id: 95b926fe-97b4-4c12-814e-6a76c6ca8c23
spl set id: be2f3b44-f371-4504-86d3-292cc8dfa062

Reported adverse events (FAERS/openFDA)#

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