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Dry Eye Test Prescribing Information

Package insert / product label
Generic name: fluorescein sodium
Dosage form: ophthalmic strip
Drug class: Ophthalmic diagnostic agents

Medically reviewed by Last updated on Jan 4, 2024.

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.

Indications and Usage for Dry Eye Test

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


Hypersensitivity to components or mercury-containing compounds.

Dry Eye Test Dosage and Administration

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.

How is Dry Eye Test supplied

Carton of 50 pouches of two strips each.

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.

Nomax, Inc. • St. Louis, MO 63123 USA

Rev. 12/13
MSN 015-153

PRINCIPAL DISPLAY PANEL - 100 Sterile Strips (50 Pouches of 2 Strips Each)

DET box

fluorescein sodium strip
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51801-008
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fluorescein Sodium (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN0.12 mg
Product Characteristics
ColorORANGE (paper is white and tip is orange) Score
ShapeRECTANGLE (with tapered end) Size52mm
FlavorImprint Code
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51801-008-1550 in 1 CARTON12/05/2013
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - Nomax Inc. (103220273)
NameAddressID/FEIBusiness Operations
Nomax Inc.103220273MANUFACTURE(51801-008)

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