FRESHKOTE LUBRICANT EYE DROPS- povidone/polyvinyl alcohol solution/ drops 
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 Lubricant Eye Drop

FreshKote Lubricant Eye Drops
Doctor Recommended

NDC 15821-101-15

THE CLEAR SOLUTION

Made in The USA

Sterile 15mL (0.5 FL. OZ.)

FreshKote Lubricant Eye Drops

Drug Facts

Active ingredients

Active ingredients......................Purpose

Polyvinyl pyrrolidone2.0%..............Lubricant

Polyvinyl alcohol 2.7%....................Lubricant

Lubricant

Uses

Warnings

For external use only.

Do not use if:

When using this product:

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) 3 or 4 times daily.

Other information

Inactive ingredients:

Boric acid, Disodium edetate dihydrate, Ethanol, Glycerin, Lecithin, Polixetonium, Polysorbate-80, Potassium chloride, Purified water, Sodium chloride

Questions call toll-free 1-866-752-6006 www.freshkote.com

Does Not Contain Benzalkonium Chloride

DO NOT USE IF IMPRINTED SEAL ON CAP IS TORN, BROKEN OR MISSING.

Manufactured for:

FOCUS Laboratories, Inc.

North Little Rock, AR 72113

Made in the USA

FreshKote Lubricant Eye Drops

INI0412 R0612

Product Carton

FRESHKOTE LUBRICANT EYE DROPS 
povidone/polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15821-101
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE K29/32 (UNII: 390RMW2PEQ) (POVIDONE K29/32 - UNII:390RMW2PEQ) POVIDONE K29/3220 g  in 1000 mL
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL27 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
POLIXETONIUM (UNII: EJT309W86C)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15821-101-1515 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/01/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/01/2006
Labeler - FOCUS Laboratories, Inc. (926378337)
Registrant - FOCUS Laboratories, Inc. (926378337)
Establishment
NameAddressID/FEIBusiness Operations
Altaire Pharmaceutical786790378analysis(15821-101) , label(15821-101) , manufacture(15821-101) , pack(15821-101) , sterilize(15821-101)

Revised: 10/2018
Document Id: 798647b0-8e4c-39dc-e053-2991aa0a716d
Set id: 6397ebc5-0670-4dc0-8660-6c0f733e6fd1
Version: 6
Effective Time: 20181031
 
FOCUS Laboratories, Inc.