Label: FUL-GLO- fluorescein sodium strip

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 22, 2012

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  • SPL UNCLASSIFIED SECTION

    Diagnostic Agent For Professional Use Only

  • SPL UNCLASSIFIED SECTION

    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.

    Figure 1

    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.

    Figure 2

    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.

    Figure 3

    Fig. 3

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

    Figure 4

    Fig. 4

  • 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 Container Label
  • PRINCIPAL DISPLAY PANEL

    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

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    FUL-GLO 
    fluorescein sodium strip
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-404
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fluorescein Sodium (UNII: 93X55PE38X) (Fluorescein - UNII:TPY09G7XIR) Fluorescein Sodium1 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17478-404-01100 in 1 CARTON06/01/2004
    11 in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other06/01/2004
    Labeler - Akorn, Inc. (062649876)