The following Structured Product Label (SPL) was submitted to the FDA by Nomax Inc. for the product Dry Eye Test (NDC 51801-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, indications, contraindications, directions for use, how supplied, principal display panel - 100 sterile strips (50 pouches of 2 strips each), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
For testing tear film stability by determining the fluorescein break-up time (FBUT).
Hypersensitivity to components or mercury-containing compounds.
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.
Carton of 50 pouches of two strips each.
Det Box (Det01)
* Please review the disclaimer below.
