Ful-Glo

Generic Name: fluorescein sodium
Dosage Form: ophthalmic strip

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.

Fluorescein Sodium Ophthalmic Strips, USP

Diagnostic Agent For Professional Use Only

Each sterile strip is impregnated with 1.0 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.

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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.

HOW SUPPLIED:

Dispenser carton containing 100 sterile strips.

100 Sterile Strips

MSN 015-084
FGBLC      Rev. 11/10
Manufactured for: Akorn, Inc.
Lake Forest, IL 60045

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 Text for Container Label:

NDC 17478-404-01 ONE STERILE STRIP To

Ful-Glo® Fluorescein Sodium Open,

Sterile Ophthalmic Strips 1.0 mg Pull Tab

Apart

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

previously opened. See box for complete information.

Principal Display Panel Text for Carton Label:

NDC 17478-404-01

Ful-Glo®

Fluorescein Sodium

Ophthalmic Strips, USP

1.0 mg

Diagnostic Agent for Professional Use Only

100 Sterile Strips

Akorn Logo

Ful-Glo 
fluorescein sodium strip
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-404
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
D&C YELLOW NO. 8 (Fluorescein) D&C YELLOW NO. 8 1.0 mg
Packaging
# Item Code Package Description
1 NDC:17478-404-01 100 APPLICATOR (100 APPLICATOR) in 1 CARTON
1 1 STRIP (1 STRIP) in 1 APPLICATOR
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)
Revised: 03/2012
 
Akorn, Inc.



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