The following Structured Product Label (SPL) was submitted to the FDA by Nomax Inc. for the product Glostrips (NDC 51801-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, indications, directions for use, how supplied, instructions for opening sterile glostrips®, an alternate method of opening, principal display panel - 300 strip carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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.
For staining the anterior segment of the eye in disclosing corneal injury, in applanation tonometry and when fitting contact lenses.
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.
Carton containing 100 or 300 sterile strips.
| 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 (Glostrips01) |
| 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 (Glostrips02) |
| 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 (Glostrips03) |
| 3. Separate the envelope at the tear, exposing the GloStrip® tip. See Fig. 4 |  Figure 4 (Glostrips04) |
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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