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Dry Eye Test

Nomax Inc.

Dry Eye Test


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

 

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

CONTRAINDICATIONS

Hypersensitivity to components or mercury-containing compounds.

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.

HOW 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)

Dry Eye Test

Dry Eye Test

Fluorescein Sodium STRIP

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:51801-008
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FLUORESCEIN SODIUM FLUORESCEIN 0.12 mg

Product Characteristics

Color Size Shape
ORANGE (paper is white and tip is orange) 52 mm RECTANGLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 POUCH
2 NDC:51801-008-15 50 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-12-05


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