Dry Eye Test

Dry Eye Test
SPL v3
SPL
SPL Set ID 04866053-f973-471e-b3bc-241fb76303a2
Route
OPHTHALMIC
Published
Effective Date 2019-12-23
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluorescein (0.12 mg)

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: orange Size: 52 mm
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-12-05

Description

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.

How Supplied

Carton of 50 pouches of two strips each.


Medication Information

Contraindications

Hypersensitivity to components or mercury-containing compounds.

How Supplied

Carton of 50 pouches of two strips each.

Description

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.

Section 42229-5

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).

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.

Principal Display Panel 100 Sterile Strips (50 Pouches of 2 Strips Each)


Structured Label Content

Contraindications (34070-3)

Hypersensitivity to components or mercury-containing compounds.

Section 42229-5 (42229-5)

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 (INDICATIONS)

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

How Supplied (HOW SUPPLIED)

Carton of 50 pouches of two strips each.

Directions for Use (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.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)