FUL-GLO- fluorescein sodium strip

FUL-GLO by

Drug Labeling and Warnings

FUL-GLO by is a Prescription medication manufactured, distributed, or labeled by Akorn, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Diagnostic Agent For Professional Use Only

SPL UNCLASSIFIED SECTION

Each sterile strip is impregnated with 0.6 mg of fluorescein sodium USP.

INDICATIONS:

For staining the anterior segment of the eye when fitting contact lenses, in disclosing corneal injury and in applanation tonometry.

DIRECTIONS FOR USE:

To ensure full fluorescence and patient comfort, the Ful-Glo impregnated tip should be moistened before application. One or two drops of sterile irrigation solution should be used for this purpose. Touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application.

NOTE: Contents may not be sterile if individual strip package has been damaged or previously opened. Store below 30°C.

INSTRUCTIONS FOR OPENING STERILE STRIPS:

1. Separate tab ends. Pull apart slowly until white handle visible. Remove from envelope.

Fig. 1

Or, for a convenient handle protector-

2. Grasp envelope firmly with two hands as shown in Fig. 2. Tear down the middle of envelope to strip.

Fig. 2

Hold the handle end of the strip firmly in the right hand as shown in Fig 3. Hold left edge of paper envelope so that tip is not held between the fingers.

Fig. 3

Snap the left portion off quickly. Strip is ready to use with a convenient handle protector.

Fig. 4

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 17478-403-03 ONE STERILE STRIP

FUL-GLO® Fluorescein Sodium

Sterile Ophthalmic Strips 0.6 mg

Contents may not be sterile if this package has been damaged or

previously opened. See box for complete information.

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 17478-403-03

FUL-GLO®

Fluorescein Sodium

Ophthalmic Strips, USP

0.6 mg

Diagnostic Agent for Professional Use Only

300 Sterile Strips

Akorn Logo

INGREDIENTS AND APPEARANCE

FUL-GLO 
fluorescein sodium strip

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 17478-403
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Fluorescein Sodium (UNII: 93X55PE38X) (Fluorescein - UNII:TPY09G7XIR)	Fluorescein Sodium	0.6 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17478-403-03	300 in 1 CARTON	06/01/2004
1		1 in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2004

Labeler - Akorn, Inc. (062649876)