Dry Eye Test

Dry Eye Test is an FDA-registered drug product whose active ingredient is FLUORESCEIN SODIUM. It is labelled by Nomax Inc. taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 51801-008, label effective 20191223. It is one of 3 FDA drug label records sharing the active ingredient FLUORESCEIN SODIUM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing FLUORESCEIN SODIUM are most often described in connection with: testing tear, film stability, fluorescein break-up, time fbut. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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.

CONTRAINDICATIONS Hypersensitivity to components or mercury-containing compounds.

FDA lists 3 drug label records with FLUORESCEIN SODIUM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Dry Eye Test used for?
INDICATIONS For testing tear film stability by determining the fluorescein break-up time (FBUT).

Who makes Dry Eye Test?
Nomax Inc. is the labeler of record for Dry Eye Test. 3 FDA label records share the active ingredient FLUORESCEIN SODIUM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Dry Eye Test come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Dry Eye Test prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FLUORESCEIN SODIUM?
Yes. 3 FDA drug label records list FLUORESCEIN SODIUM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Dry Eye Test been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.