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
FRESHKOTE®
- Manufacturer
- Harrow Eye, LLC
- Effective date
- 2026-09-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-09-11 03:01:36
Label at a glance#
ProductFRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE
Label structure13 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients Purpose
Polyvinyl Alcohol 2.7%...... Lubricant
Povidone 2.0%...................Lubricant
INDICATIONS & USAGE SECTION
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 SECTION
Warnings
For external use only
OTC - DO NOT USE SECTION
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 SECTION
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 SECTION
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 SECTION
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away
DOSAGE & ADMINISTRATION SECTION
Directions:
Instill 1 or 2 drop(s) in the affected eye(s) as needed
STORAGE AND HANDLING SECTION
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 SECTION
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 SECTION
Questions or comments?
Call toll-free +1-833-4HARROW (+1-833-442-7769)
OTC - PURPOSE SECTION
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 Spain
NDC 82667-013-10
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS
- povidone, polyvinyl alcohol solution
- POLYVINYL ALCOHOL, UNSPECIFIED
- POVIDONE
- SODIUM CHLORIDE
- EDETATE DISODIUM
- POLYSORBATE 80
- POTASSIUM CHLORIDE
- BORIC ACID
- WATER
- ALCOHOL
- EGG PHOSPHOLIPIDS
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82667-013 | 82667-013-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | ACTIB |
| POVIDONE | FZ989GH94E | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| POTASSIUM CHLORIDE | 660YQ98I10 | IACT |
| BORIC ACID | R57ZHV85D4 | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| EGG PHOSPHOLIPIDS | 1Z74184RGV | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2025-06-20 | full-release | 2026-06-01 01:03:33 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS | POVIDONE, POLYVINYL ALCOHOL SOLUTION | Harrow Eye, LLC | 049e9cc9-0663-53bc-e063-6294a90a2c4f | 2026-09-04 | Warnings | 82667-013-10 82667-013 82667001310 5ab03f28-5724-8d7c-e063-6394a90af62c 049e9cc9-0663-53bc-e063-6294a90a2c4f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.