Freshkote Preservative Free Lubricant Eye Drops

Freshkote Preservative Free Lubricant Eye Drops by

Drug Labeling and Warnings

Freshkote Preservative Free Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by Excelvision. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS- polyvinyl alcohol, unspecified, povidone solution 
Excelvision

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Freshkote Preservative Free Lubricant Eye Drops

Drug Facts

Active ingredients

Polyvinyl alcohol 2.7%

Povidone 2.0%

Purpose

Lubricant

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

Warnings

For external use only.

Do not use if

• 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

• 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

• 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

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

Directions

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

Other information

• 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

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?

Call toll-free 1-844-390-0720

Package Labeling:81372-002-01

Package Labeling:81372-002-02

FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS 
polyvinyl alcohol, unspecified, povidone solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81372-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	27 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDRIDE (UNII: 23J3BHR95O)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81372-002-01	30 in 1 BOX	06/12/2020
1		0.3 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC: 81372-002-02	1 in 1 BOX	03/13/2019
2		10 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	03/13/2019

Labeler - Excelvision (274234566)

Revised: 4/2021

Document Id: bf8f89d0-0c43-542f-e053-2995a90a3dee

34390-5

Set id: e6b73558-ea08-44b1-a616-421d9f8423e3

Version: 1

Effective Time: 20210409