Glostrips Strip
FDA Label NDC 51801-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nomax Inc. for the product Glostrips (NDC 51801-003). 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.

Label Section Quick Index

Other

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

Each strip is impregnated with 0.6 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.

How Supplied

Carton containing 100 or 300 sterile strips.

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 (Glostrips01)

Figure 1 (Glostrips01)

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 (Glostrips02)

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)

Figure 3 (Glostrips03)

3.

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

Figure 4 (Glostrips04)

Figure 4 (Glostrips04)

Principal Display Panel - 300 Strip Carton

NDC 51801-003-50

AMCON®
Laboratories, Inc.

0.6 mg

Fluorescein
GloStrips®

Fluorescein Sodium
Ophthalmic Strips USP
300 Sterile Strips

Principal Display Panel (300 Strip Carton)

Principal Display Panel (300 Strip Carton)

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