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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E), POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)
Available from:
Eyevance Pharmaceuticals
Administration route:
OPHTHALMIC
Prescription type:
OTC DRUG
Therapeutic indications:
Uses - For use as a lubricant to reduce further irritation or to relieve dryness of the eye Do not use if - Seal is damaged - Solution changes color or becomes cloudy - You are sensitive to any ingredient in this product 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 Purpose For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
Authorization status:
OTC monograph final
Authorization number:
71776-001-10

FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS- povidone, polyvinyl

alcohol solution

Eyevance Pharmaceuticals

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

LUBRICANT EYE DROPS

Active Ingredients Purpose

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

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

Us es

For use as a lubricant to reduce further irritation or to relieve dryness of the eye

Warnings

For external use only.

Do not use if

Seal is damaged

Solution changes color or becomes cloudy

You are sensitive to any ingredient in this product

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

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

Use before expiration date marked on container

Store at 20-25

C(68-77

Retain this carton for future reference

Do not freeze

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.

Purpos e

®

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

When using this product

Do not touch tip of container to any surface to avoid contamination

Replace cap after using

Shake off remaining drop before replacing cap

FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS

povidone, polyvinyl alcohol solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71776 -0 0 1

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE (UNII: FZ9 8 9 GH9 4E) (POVIDONE - UNII:FZ9 8 9 GH9 4E)

POVIDONE

20 g

in 10 0 0 mL

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 ) (POLYVINYL ALCOHOL,

UNSPECIFIED - UNII:532B59 J9 9 0 )

POLYVINYL ALCOHOL,

UNSPECIFIED

27 g

in 10 0 0 mL

Eyevance Pharmaceuticals

Inactive Ingredients

Ingredient Name

Stre ng th

BO RIC ACID (UNII: R57ZHV8 5D4)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

GLYCERIN (UNII: PDC6 A3C0 OX)

EGG PHO SPHO LIPIDS (UNII: 1Z7418 4RGV)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 )

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:71776 -0 0 1-

1 in 1 BOX

0 3/13/20 19

1

10 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt349

0 3/13/20 19

Labeler -

Eyevance Pharmaceuticals (080876046)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Exc e lVisio n

27423456 6

manufacture(71776 -0 0 1) , pack(71776 -0 0 1)

Revised: 3/2019

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