Freshkote ®

Drug Facts

Composition & Product

Active Ingredients

Polyvinyl Alcohol, Unspecified (27 g) Povidone (20 g)

Inactive Ingredients

Sodium Chloride Edetate Disodium Polysorbate 80 Potassium Chloride Boric Acid Water Alcohol Egg Phospholipids Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-09-15

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Directions:

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

Description

Active Ingredients Purpose Polyvinyl Alcohol 2.7%...... Lubricant Povidone 2.0%...................Lubricant

Section 44425-7

Other information:

Use before expiration date and discard bottle 30 days after opening

Store at 20°C to 25°C (68°F to 77°F)

Retain carton for reference

Do not freeze

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if

You experience eye pain, changes in vision, continued redness or irritation of the eye(s), or if the condition worsens or if symptoms last more than 72 hours.

Section 50567-7

When using this product

Do not touch tip of container to any surface to avoid contamination

Replace cap after using

Shake off remaining drop before replacing cap

Section 50570-1

Do not use if

Seal is damaged

Solution changes color or becomes cloudy

You are sensitive to any ingredient in this product

Section 51727-6

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.

Section 51945-4

HARROW

FRESHKOTE ^®

Preservative Free

LUBRICANT EYE DROPS

The clear solution

Temporarily Relieves Symptoms of Dry Eye

REFER TO FULL SAFETY INFORMATION PRIOR TO USE

Sterile

0.33 FL OZ (10mL)

Temporary relief from dry eye

Gentle, preservative-free drops can be used with contact lenses

Exclusive patented formulation

Unique phospholipid blend combats tear evaporation

State-of-the-art Novelia ^®multidose bottle dispenses drop with precision

FRESHKOTE ^®

Preservative Free

is the clear

solution for the

temporary relief of

dry eye symptoms

Product of France

NDC 82667-013-10

Section 53413-1

Questions or comments?

Call toll-free +1-833-4HARROW (+1-833-442-7769)

Section 55105-1

FRESHKOTE® Preservative Free is the clear solution for the temporary relief of dry eye symptoms

Section 55106-9

Active Ingredients Purpose

Polyvinyl Alcohol 2.7%...... Lubricant

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

Structured Label Content

Indications and Usage (34067-9)

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 (34068-7)

Directions:

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information:

Use before expiration date and discard bottle 30 days after opening

Store at 20°C to 25°C (68°F to 77°F)

Retain carton for reference

Do not freeze

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

You experience eye pain, changes in vision, continued redness or irritation of the eye(s), or if the condition worsens or if symptoms last more than 72 hours.

Section 50567-7 (50567-7)

When using this product

Do not touch tip of container to any surface to avoid contamination

Replace cap after using

Shake off remaining drop before replacing cap

Section 50570-1 (50570-1)

Do not use if

Seal is damaged

Solution changes color or becomes cloudy

You are sensitive to any ingredient in this product

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

HARROW

FRESHKOTE ^®

Preservative Free

LUBRICANT EYE DROPS

The clear solution

Temporarily Relieves Symptoms of Dry Eye

REFER TO FULL SAFETY INFORMATION PRIOR TO USE

Sterile

0.33 FL OZ (10mL)

Temporary relief from dry eye

Gentle, preservative-free drops can be used with contact lenses

Exclusive patented formulation

Unique phospholipid blend combats tear evaporation

State-of-the-art Novelia ^®multidose bottle dispenses drop with precision

FRESHKOTE ^®

Preservative Free

is the clear

solution for the

temporary relief of

dry eye symptoms

Product of France

NDC 82667-013-10

Section 53413-1 (53413-1)

Questions or comments?

Call toll-free +1-833-4HARROW (+1-833-442-7769)

Section 55105-1 (55105-1)

FRESHKOTE® Preservative Free is the clear solution for the temporary relief of dry eye symptoms

Section 55106-9 (55106-9)

Active Ingredients Purpose

Polyvinyl Alcohol 2.7%...... Lubricant

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

Advanced Ingredient Data

[{"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CHLORIDE", "unii": "660YQ98I10", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BORIC ACID", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EGG PHOSPHOLIPIDS", "unii": "1Z74184RGV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "ACTIB", "strengthNumerator": "27", "strengthDenominator": "1000", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1000", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "Directions: Instill 1 or 2 drop(s) in the affected eye(s) as needed", "34071-1": "Warnings For external use only", "44425-7": "Other information: Use before expiration date and discard bottle 30 days after opening Store at 20°C to 25°C (68°F to 77°F) Retain carton for reference Do not freeze", "50565-1": "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away", "50566-9": "Stop use and ask a doctor if You experience eye pain, changes in vision, continued redness or irritation of the eye(s), or if the condition worsens or if symptoms last more than 72 hours.", "50567-7": "When using this product Do not touch tip of container to any surface to avoid contamination Replace cap after using Shake off remaining drop before replacing cap", "50570-1": "Do not use if Seal is damaged Solution changes color or becomes cloudy You are sensitive to any ingredient in this product", "51727-6": "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.", "51945-4": "HARROW FRESHKOTE ® Preservative Free LUBRICANT EYE DROPS The clear solution Temporarily Relieves Symptoms of Dry Eye REFER TO FULL SAFETY INFORMATION PRIOR TO USE Sterile 0.33 FL OZ (10mL) Temporary relief from dry eye Gentle, preservative-free drops can be used with contact lenses Exclusive patented formulation Unique phospholipid blend combats tear evaporation State-of-the-art Novelia ® multidose bottle dispenses drop with precision FRESHKOTE ® Preservative Free is the clear solution for the temporary relief of dry eye symptoms Product of France NDC 82667-013-10", "53413-1": "Questions or comments? Call toll-free +1-833-4HARROW (+1-833-442-7769)", "55105-1": "FRESHKOTE® Preservative Free is the clear solution for the temporary relief of dry eye symptoms", "55106-9": "Active Ingredients Purpose Polyvinyl Alcohol 2.7%...... Lubricant Povidone 2.0%...................Lubricant"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information