{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 9
    }
  },
  "results": [
    {
      "effective_time": "20191223",
      "contraindications": [
        "CONTRAINDICATIONS Hypersensitivity to components or mercury-containing compounds."
      ],
      "instructions_for_use": [
        "Grasp free tab ends of overwrap and slowly pull apart. Peel the overwrap back until the entire strip is exposed. 2. Gently lift the exposed strip off of the overwrap without damaging the impregnated tip."
      ],
      "spl_product_data_elements": [
        "Dry Eye Test Fluorescein Sodium Fluorescein Sodium FLUORESCEIN paper is white and tip is orange with tapered end"
      ],
      "openfda": {
        "brand_name": [
          "Dry Eye Test"
        ],
        "generic_name": [
          "FLUORESCEIN SODIUM"
        ],
        "manufacturer_name": [
          "Nomax Inc."
        ],
        "product_ndc": [
          "51801-008"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "FLUORESCEIN SODIUM"
        ],
        "spl_id": [
          "7490418c-b489-4b90-bc3d-33ed71231e2d"
        ],
        "spl_set_id": [
          "04866053-f973-471e-b3bc-241fb76303a2"
        ],
        "package_ndc": [
          "51801-008-15"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "93X55PE38X"
        ]
      },
      "version": "3",
      "dosage_and_administration": [
        "DIRECTIONS FOR USE Procedure for measuring Fluorescein Break-up Time (FBUT) with Amcon Dry Eye Test Strips. 1. Apply one or two drops of non-preserved saline to the impregnated paper tip. Excess fluid will automatically fall off. Shaking is neither required nor desirable. 2. Ask the patient to look down and in. 3. Gently touch the strip to the superior temporal bulbar conjunctiva for one or two seconds. 4. Ask the patient to blink three times and open eyes naturally. 5. Conduct the FBUT measurements immediately. 6. Perform two consecutive measurements. If not consistent, conduct a third and average the results. 7. Repeat steps 1 through 6 using a new strip for the second eye FBUT values of less than 10 seconds are considered abnormal. Values less than 5 seconds are indicative of dry eye disorder. Values of 5 to 9 seconds are borderline dry eye. NOTE: The contents may not be sterile if the individual strip package has been damaged or previously opened. This product is intended for external use only. Keep out of reach of children. Store below 30°C."
      ],
      "spl_unclassified_section": [
        "Dry Eye Test Fluorescein Sodium Ophthalmic Strips U.S.P. diagnostic agent is for professional use only Each strip is impregnated with 0.12 mg of fluorescein sodium USP.",
        "Nomax, Inc. • St. Louis, MO 63123 USA Rev. 12/13 MSN 015-153"
      ],
      "how_supplied": [
        "HOW SUPPLIED Carton of 50 pouches of two strips each."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 100 Sterile Strips (50 Pouches of 2 Strips Each) DET box"
      ],
      "indications_and_usage": [
        "INDICATIONS For testing tear film stability by determining the fluorescein break-up time (FBUT)."
      ],
      "set_id": "04866053-f973-471e-b3bc-241fb76303a2",
      "id": "7490418c-b489-4b90-bc3d-33ed71231e2d"
    }
  ]
}