{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-02",
    "results": {
      "skip": 0,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS povidone, polyvinyl alcohol solution SODIUM CHLORIDE EDETATE DISODIUM POLYSORBATE 80 POTASSIUM CHLORIDE BORIC ACID WATER ALCOHOL EGG PHOSPHOLIPIDS GLYCERIN POLYVINYL ALCOHOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE POVIDONE"
      ],
      "active_ingredient": [
        "Active Ingredients Purpose Polyvinyl Alcohol 2.7%...... Lubricant Povidone 2.0%...................Lubricant"
      ],
      "indications_and_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"
      ],
      "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"
      ],
      "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"
      ],
      "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."
      ],
      "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_and_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."
      ],
      "questions": [
        "Questions or comments? Call toll-free +1-833-4HARROW (+1-833-442-7769)"
      ],
      "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 Carton"
      ],
      "set_id": "049e9cc9-0663-53bc-e063-6294a90a2c4f",
      "id": "38076a9a-6686-c97f-e063-6394a90acc29",
      "effective_time": "20250620",
      "version": "3",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS"
        ],
        "generic_name": [
          "POVIDONE, POLYVINYL ALCOHOL SOLUTION"
        ],
        "manufacturer_name": [
          "Harrow Eye, LLC"
        ],
        "product_ndc": [
          "82667-013"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POLYVINYL ALCOHOL, UNSPECIFIED",
          "POVIDONE"
        ],
        "rxcui": [
          "630977"
        ],
        "spl_id": [
          "38076a9a-6686-c97f-e063-6394a90acc29"
        ],
        "spl_set_id": [
          "049e9cc9-0663-53bc-e063-6294a90a2c4f"
        ],
        "package_ndc": [
          "82667-013-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "532B59J990",
          "FZ989GH94E"
        ]
      }
    }
  ]
}