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
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Updated August 24, 2013
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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.Close
For staining the anterior segment of the eye in disclosing corneal injury, in applanation tonometry and when fitting contact lenses.Close
- 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.Close
- SPL UNCLASSIFIED SECTION
Nomax, Inc. • St. Louis, MO 63123 USA
- INSTRUCTIONS FOR OPENING STERILE GLOSTRIPS®
- Grasp free tab ends of wrapping and slowly pull apart. When the white paper handle becomes visible, remove the GloStrip ® from the envelope.
An Alternate Method of Opening
- Grasp envelope firmly with two hands as shown in Fig. 2 below. Tear the envelope from both its edges to the strip handle.
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
Separate the envelope at the tear, exposing the GloStrip® tip. See Fig. 4
- PRINCIPAL DISPLAY PANEL - 300 Strip Carton
1.0 mg Fluorescein Sodium
Ophthalmic Strips USP
300 Sterile Strips
- INGREDIENTS AND APPEARANCE
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)