GloStrips

Nomax Inc.

GloStrips

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACTION
• INDICATIONS
• GLOSTRIPS CONTRAINDICATIONS
• DIRECTIONS FOR USE
• NOTE
  • CAUTION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 100 Strip Carton

FULL PRESCRIBING INFORMATION

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.

GLOSTRIPS 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.

Grasp free tab ends of wrapping and slowly pull apart. When the white paper handle becomes visible, remove the GloStrip^® from the envelope.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. 3Separate the envelope at the tear, exposing the GloStrip^® tip. See Fig. 4

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INSTRUCTIONS FOR OPENING STERILE GLOSTRIPS®
Fig. 1
An Alternate Method of Opening:
Fig. 2
Fig. 3
Fig. 4

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

GloStrips Rose Bengal Sodium STRIP Product Information Product Type Human prescription drug label Item Code (Source) NDC:51801-004 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROSE BENGAL SODIUM Rose Bengal AT 1.3 mg Product Characteristics Color Size Shape WHITE 52 mm RECTANGLE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 POUCH 2 NDC:51801-004-40 100 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 2013-08-20