FDA Label for Glostrips
View Indications, Usage & Precautions
Glostrips Product Label
The following document was submitted to the FDA by the labeler of this product Nomax Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Rose Bengal Ophthalmic Strips
diagnostic agent is for professional use only
Each strip is impregnated with 1.3 mg of Rose Bengal.
Action
As a vital stain, Rose Bengal stains both the nuclei and cell walls of dead or degenerated epithelial cells of the cornea and conjunctiva. Rose Bengal will also stain the mucus of the precorneal tear film.
Indications
Rose Bengal ophthalmic strips are used as a diagnostic agent in routine ocular examinations or when superficial conjunctiva or corneal tissue change is suspected. Rose Bengal ophthalmic strips can also serve as an effective aid in the diagnosis of keratoconjunctivitis sicca, keratitis, abrasions or corrosions as well as the detection of foreign bodies.
Contraindications
Known hypersensitivity to Rose Bengal.
Directions For Use
To ensure optimal staining and patient comfort, the GloStrip impregnated tip should be moistened with one or two drops of sterile, isotonic saline or irrigating solution before application. Shake off excess solution and 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.
Caution
Take care not to stain clothing.
How Supplied
Dispenser carton containing 100 sterile strips.
Instructions For Use
| 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. | Fig. 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. | Fig. 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 | Fig. 3 |
| 3.Separate the envelope at the tear, exposing the GloStrip® tip. See Fig. 4 |
|
Other
Nomax, Inc. • St. Louis, MO 63123 USA
Rev. 08/13
MSN 015-059
Principal Display Panel - 100 Strip Carton
NDC 51801-004-40
Amcon®
Laboratories, Inc.
Rose Bengal
GloStrips®
1.3 mg Rose Bengal
Ophthalmic Strips USP
100 Sterile Strips
* Please review the disclaimer below.