FRESHKOTE LUBRICANT EYE DROPS- povidone/polyvinyl alcohol solution/ drops

FreshKote Lubricant Eye Drops by

Drug Labeling and Warnings

FreshKote Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by FOCUS Laboratories, Inc., Altaire Pharmaceutical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FreshKote Lubricant Eye Drops Doctor Recommended

SPL UNCLASSIFIED SECTION

NDC: 15821-101-15

THE CLEAR SOLUTION

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Made in The USA

Sterile 15mL (0.5 FL. OZ.)

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FreshKote Lubricant Eye Drops

Drug Facts

Active ingredients

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

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

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

PURPOSE

Lubricant

Uses

• For use as a lubricant to prevent 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.

When using this product:

• Do not touch tip of container to any surface to avoid contamination.
• Replace cap after using.

Stop use and ask a doctor if:

• you experience eye pain.
• you experience changes in vision.
• you experience continued redness or irritation.
• the 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.

Directions

Instill 1 or 2 drop(s) in the affected eye(s) 3 or 4 times daily.

Other information

• Store at 15 O-30 OC (58 O-86 OF)
• Retain outer carton for full product drug facts.

Inactive ingredients:

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

SPL UNCLASSIFIED SECTION

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

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Does Not Contain Benzalkonium Chloride

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

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Manufactured for:

FOCUS Laboratories, Inc.

North Little Rock, AR 72113

SPL UNCLASSIFIED SECTION

Made in the USA

FreshKote Lubricant Eye Drops

INI0412 R0612

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESHKOTE LUBRICANT EYE DROPS 
povidone/polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15821-101
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE K29/32 (UNII: 390RMW2PEQ) (POVIDONE K29/32 - UNII:390RMW2PEQ)	POVIDONE K29/32	20 g  in 1000 mL
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL	27 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15821-101-15	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/01/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	04/01/2006

Labeler - FOCUS Laboratories, Inc. (926378337)

Registrant - FOCUS Laboratories, Inc. (926378337)

Establishment
Name	Address	ID/FEI	Business Operations
Altaire Pharmaceutical		786790378	analysis(15821-101) , label(15821-101) , manufacture(15821-101) , pack(15821-101) , sterilize(15821-101)