FDA Label for Dry Eye Test
View Indications, Usage & Precautions
Dry Eye Test Product Label
The following document was submitted to the FDA by the labeler of this product Nomax Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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.
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.
Indications
For testing tear film stability by determining the fluorescein break-up time (FBUT).
Contraindications
Hypersensitivity to components or mercury-containing compounds.
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.
How Supplied
Carton of 50 pouches of two strips each.
Principal Display Panel - 100 Sterile Strips (50 Pouches Of 2 Strips Each)
* Please review the disclaimer below.