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  5. Label Information: Freshkote Preservative Free Lubricant Eye Drops

FDA Label for Freshkote Preservative Free Lubricant Eye Drops

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. STORAGE AND HANDLING
    9. INACTIVE INGREDIENT
    10. OTC - PURPOSE
    11. OTC - WHEN USING
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freshkote Preservative Free Lubricant Eye Drops Product Label

The following document was submitted to the FDA by the labeler of this product Eyevance Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients            Purpose

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

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


Indications & Usage



Uses

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

Warnings



Warnings

For external use only.


Otc - Do Not Use



Do not use if

  • Seal is damaged
  • Solution changes color or becomes cloudy
  • You are sensitive to any ingredient in this product

Otc - Stop Use



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

Otc - 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.


Dosage & Administration



Directions

Instill 1 or 2 drop(s) in the affected eye(s) as needed


Storage And Handling



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 Ingredient



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.


Otc - Purpose



Purpose

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


Otc - When Using



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

* Please review the disclaimer below.