FRESHKOTE PRESERVATIVE FREE LUBRICATING EYE DROPS SINGLE USE- povidone, polyvinyl alcohol solution 
FOCUS Laboratories, Inc.

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 Lubricating Eye Drops: Single Use

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.

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

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FRESHKOTE PRESERVATIVE FREE LUBRICATING EYE DROPS SINGLE USE 
povidone, polyvinyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15821-105
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:15821-105-036 in 1 BOX06/29/2018
15 in 1 POUCH
10.3 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34906/29/2018
Labeler - FOCUS Laboratories, Inc. (926378337)
Establishment
NameAddressID/FEIBusiness Operations
ExcelVision274234566manufacture(15821-105) , pack(15821-105)

Revised: 7/2018
Document Id: 95b926fe-97b4-4c12-814e-6a76c6ca8c23
Set id: be2f3b44-f371-4504-86d3-292cc8dfa062
Version: 2
Effective Time: 20180725
 
FOCUS Laboratories, Inc.