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FreshKote Preservative Free Lubricant Eye Drops

Medically reviewed by Drugs.com. Last updated on Mar 14, 2019.

Dosage form: solution
Ingredients: POVIDONE 20g in 1000mL, POLYVINYL ALCOHOL, UNSPECIFIED 27g in 1000mL
Labeler: Eyevance Pharmaceuticals
NDC Code: 71776-001

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

FRESHKOTE ®

Preservative Free

LUBRICANT EYE DROPS

Active Ingredients            Purpose

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

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

Uses

  • 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 οC(68-77 οF)
  • 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.

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

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:71776-001
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE (POVIDONE) POVIDONE20 g  in 1000 mL
POLYVINYL ALCOHOL, UNSPECIFIED (POLYVINYL ALCOHOL, UNSPECIFIED) POLYVINYL ALCOHOL, UNSPECIFIED27 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID 
EDETATE DISODIUM 
ALCOHOL 
GLYCERIN 
EGG PHOSPHOLIPIDS 
POLYSORBATE 80 
POTASSIUM CHLORIDE 
SODIUM CHLORIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:71776-001-101 BOTTLE, DROPPER in 1 BOX
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/13/2019
Labeler - Eyevance Pharmaceuticals (080876046)
Establishment
NameAddressID/FEIOperations
ExcelVision274234566manufacture(71776-001), pack(71776-001)

 
Eyevance Pharmaceuticals