FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS- povidone, polyvinyl alcohol solution 
Eyevance Pharmaceuticals

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FRESHKOTE ®







Preservative Free







LUBRICANT EYE DROPS

Active Ingredients            Purpose

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

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

Uses

Warnings

For external use only.

Do not use if

Stop use and ask a doctor if

Keep out of reach of children

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

Directions

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

Other information

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

When using this product

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FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS 
povidone, polyvinyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71776-001
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE20 g  in 1000 mL
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED27 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71776-001-101 in 1 BOX03/13/2019
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:71776-001-0330 in 1 BOX12/06/2020
20.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01803/13/2019
Labeler - Eyevance Pharmaceuticals (080876046)
Establishment
NameAddressID/FEIBusiness Operations
ExcelVision274234566manufacture(71776-001) , pack(71776-001)

Revised: 10/2023
Document Id: 0700d0a1-3b89-10b8-e063-6294a90a819e
Set id: f51c50c3-43ae-4169-9d2b-22b239461dd1
Version: 5
Effective Time: 20231005
 
Eyevance Pharmaceuticals