CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Hypersensitivity to components or mercury-containing compounds.

DOSAGE & ADMINISTRATION SECTION.

DIRECTIONS FOR USE. Procedure for measuring FluoresceinBreak-up Time (FBUT) with Amcon Dry Eye Test Strips.1. Apply one or two drops of non-preserved saline to theimpregnated paper tip. Excess fluid will automatically fall off.Shaking is neitherrequired nor desirable.2. Ask the patient to look down and in.3. Gently touch the strip to the superior temporal bulbar conjunctivafor 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, conducta third and average the results.7. Repeat steps through using new strip for the second eyeFBUT values of less than 10 seconds are considered abnormal. Values less than seconds are indicative of dry eye disorder. Values of to 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 30C.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Carton of 50 pouches of two strips each.

INDICATIONS & USAGE SECTION.

INDICATIONS. For testing tear film stability by determining the fluorescein break-up time (FBUT).

INSTRUCTIONS FOR USE SECTION.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 100 Sterile Strips (50 Pouches of Strips Each). DET box.

SPL UNCLASSIFIED SECTION.

Dry Eye Test Fluorescein Sodium Ophthalmic Strips U.S.P. diagnostic agent is for professional use onlyEach strip is impregnated with 0.12 mg of fluorescein sodium USP.