FDA Label for Freshkote Preservative Free Lubricant Eye Drops
View Indications, Usage & Precautions
Freshkote Preservative Free Lubricant Eye Drops Product Label
The following document was submitted to the FDA by the labeler of this product Harrow Eye, Llc. 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
For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
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 - 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
Otc - Stop Use
Stop use and ask a doctor if
You experience eye pain, changes in vision, continued redness or irritation of the eye(s), or if the condition worsens or if 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 and discard bottle 30 days after opening
Store at 20°C to 25°C (68°F to 77°F)
Retain carton for 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 - Questions
Questions or comments?
Call toll-free +1-833-4HARROW (+1-833-442-7769)
Otc - Purpose
FRESHKOTE® Preservative Free is the clear solution for the temporary relief of dry eye symptoms
Package Label.Principal Display Panel
HARROW
FRESHKOTE®
Preservative Free
LUBRICANT EYE DROPS
The clear solution
Temporarily Relieves Symptoms of Dry Eye
REFER TO FULL SAFETY INFORMATION PRIOR TO USE
Sterile
0.33 FL OZ (10mL)
Temporary relief from dry eye
Gentle, preservative-free drops can be used with contact lenses
Exclusive patented formulation
Unique phospholipid blend combats tear evaporation
State-of-the-art Novelia® multidose bottle dispenses drop with precision
FRESHKOTE®
Preservative Free
is the clear
solution for the
temporary relief of
dry eye symptoms
Product of France
NDC 82667-013-10
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