Glostrips Strip
FDA Label NDC 51801-004

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 51801-004). 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 description, action, indications, contraindications, directions for use, note, caution, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Description

→ Action

→ Indications

→ Contraindications

→ Directions For Use

→ Note

→ Caution

→ How Supplied

→ Instructions For Use

→ Other

→ Principal Display Panel - 100 Strip Carton

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 Figure (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.	Fig. 2 Figure (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	Fig. 3 Figure (Glostrips03)
3.Separate the envelope at the tear, exposing the GloStrip^®tip. See Fig. 4	Fig. 4 Figure (Glostrips04)