Label: GLOSTRIPS- fluorescein sodium strip

  • NDC Code(s): 51801-009-40, 51801-009-50
  • Packager: Nomax Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated December 23, 2019

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  • 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.

  • INDICATIONS

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

  • 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.

  • HOW SUPPLIED

    Carton containing 100 or 300 sterile strips.

  • SPL UNCLASSIFIED SECTION

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

    Rev. 07/13
    MSN 015-244

  • 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

  • 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
  • INGREDIENTS AND APPEARANCE
    GLOSTRIPS  
    fluorescein sodium strip
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51801-009
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fluorescein Sodium (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN1 mg
    Product Characteristics
    ColorORANGE (paper is white and tip is orange) Score    
    ShapeRECTANGLE (with tapered end) Size52mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51801-009-50300 in 1 CARTON07/30/2013
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:51801-009-40100 in 1 CARTON07/30/2013
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER07/30/2013
    Labeler - Nomax Inc. (103220273)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nomax Inc.103220273MANUFACTURE(51801-009)
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