Label: FUL-GLO- d&c yellow no. 8 strip 

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

Drug Label Information

Updated 03/12

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  • SPL UNCLASSIFIED SECTION

    Diagnostic Agent For Professional Use Only

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  • SPL UNCLASSIFIED SECTION

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

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  • 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.

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  • 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

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-403-03 ONE STERILE STRIP To

    FUL-GLO® Fluorescein Sodium Open,

    Sterile Ophthalmic Strips 0.6 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 Container Label
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  • 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

    Principal Display Panel Text for Carton Label
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  • INGREDIENTS AND APPEARANCE
    FUL-GLO 
    fluorescein sodium strip
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-403
    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 0.6 mg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17478-403-03 300 in 1 CARTON
    1 1 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)
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