FreshKote Lubricant Eye Drops

Manufacturer: FOCUS Laboratories, Inc. | Altaire Pharmaceutical
Effective date: 2018-10-31
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-02 00:48:04

Label at a glance#

ProductFreshKote Lubricant Eye Drops

Active ingredientPOVIDONE K29/32, POLYVINYL ALCOHOL

Label structure16 sections

Indications and uses

For use as a lubricant to prevent 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 or 2 drop(s) in the affected eye(s) 3 or 4 times daily.

Storage and handling

Store at 15 O -30 O C (58 O -86 O F) Retain outer carton for full product drug facts.

Contacts and useful links#

PhoneLabel contact1-866-752-6006

Websitewww.freshkote.com

www.freshkote.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 15821-101-15

THE CLEAR SOLUTION

SPL UNCLASSIFIED SECTION

Made in The USA

Sterile 15mL (0.5 FL. OZ.)

SPL UNCLASSIFIED SECTION

FreshKote Lubricant Eye Drops

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients......................Purpose

Polyvinyl pyrrolidone2.0%..............Lubricant

Polyvinyl alcohol 2.7%....................Lubricant

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

For use as a lubricant to prevent 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:

solution changes color or becomes cloudy.
you are sensitive to any ingredient in this product.

When using this product:

Do not touch tip of container to any surface to avoid contamination.
Replace cap after using.

Stop use and ask a doctor if:

you experience eye pain.
you experience changes in vision.
you experience continued redness or irritation.
the 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drop(s) in the affected eye(s) 3 or 4 times daily.

Other information

STORAGE AND HANDLING SECTION

Store at 15 ^O-30 ^OC (58 ^O-86 ^OF)
Retain outer carton for full product drug facts.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Boric acid, Disodium edetate dihydrate, Ethanol, Glycerin, Lecithin, Polixetonium, Polysorbate-80, Potassium chloride, Purified water, Sodium chloride

SPL UNCLASSIFIED SECTION

Questions call toll-free 1-866-752-6006 www.freshkote.com

SPL UNCLASSIFIED SECTION

Does Not Contain Benzalkonium Chloride

DO NOT USE IF IMPRINTED SEAL ON CAP IS TORN, BROKEN OR MISSING.

SPL UNCLASSIFIED SECTION

Manufactured for:

FOCUS Laboratories, Inc.

North Little Rock, AR 72113

SPL UNCLASSIFIED SECTION

Made in the USA

FreshKote Lubricant Eye Drops

INI0412 R0612

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Carton

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0315821101158	GTIN-13: 0315821101158 EAN-13: 0315821101158 GTIN-12: 315821101158 UPC-A: 315821101158 GTIN storage (14 digits): 00315821101158	FreshKoteStockCarton621.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
15821-101-15	2020-01-31	C162847	48780-1	9d75b9d1-1488-f424-e053-dadaa90a57ce	FreshKote Lubricant Eye Drop

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15821-101	FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]	6	Legacy NDC	20181031_6397ebc5-0670-4dc0-8660-6c0f733e6fd1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
15821-101-15	ML - Milliliter	15821-101	138ae3d7-fff1-4b2a-8817-92f89fc1d5ba	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
POLYVINYL ALCOHOL	ACTIVE INGREDIENT	532B59J990	4
POVIDONE K29/32	ACTIVE INGREDIENT	390RMW2PEQ	4
POLYVINYL ALCOHOL	ACTIVE MOIETY	532B59J990	4
POVIDONE K29/32	ACTIVE MOIETY	390RMW2PEQ	4
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	4
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	4
POLIXETONIUM	INACTIVE INGREDIENT	EJT309W86C	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	4
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

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

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

FreshKote Lubricant Eye Drops
Povidone/Polyvinyl Alcohol
BORIC ACID
POTASSIUM CHLORIDE
POLIXETONIUM
GLYCERIN
POLYSORBATE 80
SODIUM CHLORIDE
EDETATE DISODIUM
LECITHIN, SOYBEAN
WATER
POVIDONE K29/32
POLYVINYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
15821-101	15821-101-15

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
Name	UNII	Kind
BORIC ACID	R57ZHV85D4	IACT
POTASSIUM CHLORIDE	660YQ98I10	IACT
POLIXETONIUM	EJT309W86C	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
WATER	059QF0KO0R	IACT
POVIDONE K29/32	390RMW2PEQ	ACTIB
POLYVINYL ALCOHOL	532B59J990	ACTIB

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 7 · 406 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION/ DROPS / OPHTHALMIC	0.14 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVITREAL	0.02 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVASCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.53 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1800 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	CAPSULE / ORAL	62 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAMUSCULAR		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INFILTRATION		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAMUSCULAR	4 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / TOPICAL	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / OPHTHALMIC		55 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBMUCOSAL		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
798647b0-8e4c-39dc-e053-2991aa0a716d			6397ebc5-0670-4dc0-8660-6c0f733e6fd1	2018-10-31	Warnings	Exact identifier spl id: 798647b0-8e4c-39dc-e053-2991aa0a716d spl set id: 6397ebc5-0670-4dc0-8660-6c0f733e6fd1

Reported adverse events (FAERS/openFDA)#

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