FDA Label for Ful-glo
View Indications, Usage & Precautions
Ful-glo Product Label
The following document was submitted to the FDA by the labeler of this product Akorn. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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.
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.
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.
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.
Snap the left portion off quickly. Strip is ready to use with a convenient handle protector.
Package Label.Principal Display Panel
Principal Display Panel Text for Container Label:
NDC 17478-404-01 ONE STERILE STRIP
FUL-GLO® Fluorescein Sodium
Sterile Ophthalmic Strips 1 mg
Contents may not be sterile if this package has been damaged or
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 mg
Diagnostic Agent for Professional Use Only
100 Sterile Strips
Akorn Logo
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