Label: GLOSTRIPS - fluorescein sodium strip

  • NDC Code(s): 51801-009-40, 51801-009-50
  • Packager: Nomax Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated August 24, 2013

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Fluorescein Sodium Ophthalmic Strips U.S.P. diagnostic agent is for professional use only

    Each strip is impregnated with 1.0 mg of fluorescein sodium USP.

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  • INDICATIONS

    For staining the anterior segment of the eye in disclosing corneal injury, in applanation tonometry and when fitting contact lenses.

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  • DIRECTIONS FOR USE

    To ensure full fluorescence and patient comfort, the GloStrip® impregnated tip should be moistened with one or two drops of sterile, isotonic saline or irrigating solution before application.

    Touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application.

    NOTE: The contents may not be sterile if the individual strip package has been damaged or previously opened. This product is intended for external use only. Keep out of reach of children. Store below 30°C.

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  • HOW SUPPLIED

    Carton containing 100 or 300 sterile strips.

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  • SPL UNCLASSIFIED SECTION

    Nomax, Inc. • St. Louis, MO 63123 USA

    Rev. 07/13
    MSN 015-244

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  • INSTRUCTIONS FOR OPENING STERILE GLOSTRIPS®

    1.
    Grasp free tab ends of wrapping and slowly pull apart. When the white paper handle becomes visible, remove the GloStrip ® from the envelope.
    Figure 1

    An Alternate Method of Opening

    1.
    Grasp envelope firmly with two hands as shown in Fig. 2 below. Tear the envelope from both its edges to the strip handle.
    Figure 2
    2.

    Hold the handle end of the GloStrip® with the left hand and the paper envelope without holding the tip with the right hand. See Fig. 3

    Figure 3
    3.

    Separate the envelope at the tear, exposing the GloStrip® tip. See Fig. 4

    Figure 4
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  • PRINCIPAL DISPLAY PANEL - 300 Strip Carton

    NDC 51801-009-50

    AMCON®
    Laboratories, Inc.

    Fluorescein
    GloStrips®1.0

    1.0

    1.0 mg Fluorescein Sodium
    Ophthalmic Strips USP
    300 Sterile Strips

    PRINCIPAL DISPLAY PANEL - 300 Strip Carton
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  • INGREDIENTS AND APPEARANCE
    GLOSTRIPS  
    fluorescein sodium strip
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51801-009
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fluorescein Sodium (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN 1 mg
    Product Characteristics
    Color ORANGE (paper is white and tip is orange) Score     
    Shape RECTANGLE (with tapered end) Size 52mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51801-009-50 300 in 1 CARTON
    1 1 in 1 POUCH
    2 NDC:51801-009-40 100 in 1 CARTON
    2 1 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 07/30/2013
    Labeler - Nomax Inc. (103220273)
    Establishment
    Name Address ID/FEI Business Operations
    Nomax Inc. 103220273 MANUFACTURE(51801-009)
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