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  5. Label Information: Freshkote Preservative Free Lubricating Eye Drops Single Use

FDA Label for Freshkote Preservative Free Lubricating Eye Drops Single Use

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    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. INDICATIONS & USAGE
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freshkote Preservative Free Lubricating Eye Drops Single Use Product Label

The following document was submitted to the FDA by the labeler of this product Focus Laboratories, Inc.. 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


Otc - Purpose



Uses

  • For use as a protectant to prevent 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 20-25οC(68-77οF)
  • Retain this carton for future reference

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.


Indications & Usage



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


* Please review the disclaimer below.