FRESHKOTE PRESERVATIVE FREE LUBRICATING EYE DROPS- povidone, polyvinyl alcohol solution

FreshKote Preservative Free Lubricating Eye Drops by

Drug Labeling and Warnings

FreshKote Preservative Free Lubricating Eye Drops by is a Otc medication manufactured, distributed, or labeled by FOCUS Laboratories, Inc., ExcelVision. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients            Purpose

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

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

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use if

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

Directions

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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

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.

PURPOSE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESHKOTE PRESERVATIVE FREE LUBRICATING EYE DROPS 
povidone, polyvinyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15821-108
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	20 g  in 1000 mL
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	27 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15821-108-10	1 in 1 BOX	06/29/2018
1		10 mL in 1 BOTTLE, DROPPER; 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	06/29/2018

Labeler - FOCUS Laboratories, Inc. (926378337)

Establishment
Name	Address	ID/FEI	Business Operations
ExcelVision		274234566	manufacture(15821-108) , pack(15821-108)