{
  "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": "2026-07-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "GenTeal Tears Moderate Preservative Free dextran 70, hypromellose 2910 Hypromellose 2910 (4000 Mpa.s) Hypromellose 2910 (4000 Mpa.s) Dextran 70 Dextran 70 Potassium Chloride Water Sodium Borate Hydrochloric Acid Sodium Hydroxide Sodium Chloride Carton Label Carton Label"
      ],
      "active_ingredient": [
        "Active Ingredients Purpose Dextran 70 0.1% Lubricant Hypromellose 2910 0.3% Lubricant"
      ],
      "active_ingredient_table": [
        "<table border=\"1\" cellpadding=\"4\" cellspacing=\"0\" width=\"40%\"><tbody><tr><td><content styleCode=\"bold\">Active Ingredients</content></td><td align=\"right\"><content styleCode=\"bold\">Purpose</content></td></tr><tr><td>Dextran 70 0.1%</td><td align=\"right\">Lubricant</td></tr><tr><td>Hypromellose 2910 0.3%</td><td align=\"right\">Lubricant</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active Ingredients Purpose Dextran 70 0.1% Lubricant Hypromellose 2910 0.3% Lubricant",
        ""
      ],
      "purpose_table": [
        "<table border=\"1\" cellpadding=\"4\" cellspacing=\"0\" width=\"40%\"><tbody><tr><td><content styleCode=\"bold\">Active Ingredients</content></td><td align=\"right\"><content styleCode=\"bold\">Purpose</content></td></tr><tr><td>Dextran 70 0.1%</td><td align=\"right\">Lubricant</td></tr><tr><td>Hypromellose 2910 0.3%</td><td align=\"right\">Lubricant</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Uses 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 this solution changes color or becomes cloudy if you are sensitive to any ingredient in this product"
      ],
      "when_using": [
        "When using this product to avoid contamination, do not touch tip of container to any surface do not reuse once opened, discard"
      ],
      "stop_use": [
        "Stop use and ask a doctor if you experience any of the following: eye pain changes in vision continued redness or irritation of the eye condition worsens or persists for 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 put 1 or 2 drops in the affected eye(s) as needed."
      ],
      "other_safety_information": [
        "Other information store are room temperature 15 o – 25 o C (59 o – 77 o F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients potassium chloride, purified water, sodium borate, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH."
      ],
      "questions": [
        "Questions? In the U.S. call 1 (800) 757-9195 (Mon-Fri 9AM-5PM CST) alcon.medinfo@alcon.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL PRESERVATIVE FREE Moderate DRY EYE SYMPTOM RELIEF GenTeal ® Tears LUBRICANT EYE DROPS LIQUID DROPS Fast, Soothing Relief Preservative Free Formula Previously TEARS NATURALE ® FREE LUBRICANT EYE DROPS STERILE 36 Single-Use Vials 0.9 mL (0.03 FL OZ) Each Alcon GenTeal ® Tears Lubricant Eye Drops Preservative Free provide lasting relief for moderate dry eye with the convenience of a vial. TAMPER EVIDENTY: Do not use if vial is damaged or opened. Distributed by: Alcon Laboratories, Inc., 6201 South Freeway Fort Worth, Texas 76134 Country of Origin: France 435581"
      ],
      "set_id": "37686e54-e64d-47c8-b082-b944a23cf6f1",
      "id": "f7885429-659f-40b7-bbd7-d8680d1912f2",
      "effective_time": "20231214",
      "version": "8",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "GenTeal Tears Moderate Preservative Free"
        ],
        "generic_name": [
          "DEXTRAN 70, HYPROMELLOSE 2910"
        ],
        "manufacturer_name": [
          "Alcon Laboratories, Inc."
        ],
        "product_ndc": [
          "0065-8063"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "DEXTRAN 70",
          "HYPROMELLOSE 2910 (4000 MPA.S)"
        ],
        "rxcui": [
          "309714"
        ],
        "spl_id": [
          "f7885429-659f-40b7-bbd7-d8680d1912f2"
        ],
        "spl_set_id": [
          "37686e54-e64d-47c8-b082-b944a23cf6f1"
        ],
        "package_ndc": [
          "0065-8063-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000184175",
          "N0000009361",
          "N0000010288"
        ],
        "pharm_class_epc": [
          "Plasma Volume Expander [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Intravascular Volume [PE]"
        ],
        "pharm_class_moa": [
          "Osmotic Activity [MoA]"
        ],
        "unii": [
          "7SA290YK68",
          "RN3152OP35"
        ]
      }
    }
  ]
}