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NDC 51801-0008-15 Dry Eye Test 0.12 mg/1 Details
Dry Eye Test 0.12 mg/1
Dry Eye Test is a OPHTHALMIC STRIP in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Nomax Inc.. The primary component is FLUORESCEIN SODIUM.
Product Information
NDC | 51801-0008 |
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Product ID | 51801-008_7490418c-b489-4b90-bc3d-33ed71231e2d |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Dry Eye Test |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Fluorescein Sodium |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | STRIP |
Route | OPHTHALMIC |
Active Ingredient Strength | 0.12 |
Active Ingredient Units | mg/1 |
Substance Name | FLUORESCEIN SODIUM |
Labeler Name | Nomax Inc. |
Pharmaceutical Class | Diagnostic Dye [EPC], Dyes [MoA] |
DEA Schedule | n/a |
Marketing Category | UNAPPROVED DRUG OTHER |
Application Number | n/a |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 51801-0008-15 (51801000815)
NDC Package Code | 51801-008-15 |
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Billing NDC | 51801000815 |
Package | 50 POUCH in 1 CARTON (51801-008-15) / 2 STRIP in 1 POUCH |
Marketing Start Date | 2013-12-05 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 04866053-f973-471e-b3bc-241fb76303a2 Details
SPL UNCLASSIFIED SECTION
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.
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.
INGREDIENTS AND APPEARANCE
DRY EYE TEST
fluorescein sodium strip |
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Labeler - Nomax Inc. (103220273) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Nomax Inc. | 103220273 | MANUFACTURE(51801-008) |