Label: DRY EYE TEST- fluorescein sodium strip
- NDC Code(s): 51801-008-15
- Packager: Nomax Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated December 23, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- INDICATIONS
- CONTRAINDICATIONS
-
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
- 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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 Sterile Strips (50 Pouches of 2 Strips Each)
-
INGREDIENTS AND APPEARANCE
DRY EYE TEST
fluorescein sodium stripProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51801-008 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fluorescein Sodium (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN 0.12 mg Product Characteristics Color ORANGE (paper is white and tip is orange) Score Shape RECTANGLE (with tapered end) Size 52mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51801-008-15 50 in 1 CARTON 12/05/2013 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 12/05/2013 Labeler - Nomax Inc. (103220273) Establishment Name Address ID/FEI Business Operations Nomax Inc. 103220273 MANUFACTURE(51801-008)
