Ful-glo
FDA Label NDC 17478-404

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akorn for the product Ful-glo (NDC 17478-404). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, indications:, directions for use:, how supplied:, instructions for opening sterile strips:, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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

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

* Please review the disclaimer below.