GloStrips

Nomax Inc.

GloStrips 1.0

FULL PRESCRIBING INFORMATION: CONTENTS*

• INDICATIONS
• DIRECTIONS FOR USE
• HOW SUPPLIED
• INSTRUCTIONS FOR OPENING STERILE GLOSTRIPS
  • An Alternate Method of Opening
• PRINCIPAL DISPLAY PANEL - 300 Strip Carton

FULL PRESCRIBING INFORMATION

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.

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.

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.

HOW SUPPLIED

Carton containing 100 or 300 sterile strips.

Nomax, Inc. • St. Louis, MO 63123 USA

Rev. 07/13
MSN 015-244

INSTRUCTIONS FOR OPENING STERILE GLOSTRIPS

Grasp free tab ends of wrapping and slowly pull apart. When the white paper handle becomes visible, remove the GloStrip^® from the envelope.

1.

An Alternate Method of Opening

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. 3

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

1.

2.

3.

PRINCIPAL DISPLAY PANEL - 300 Strip Carton

NDC 51801-009-50

AMCON_®
Laboratories, Inc.

Fluorescein
GloStrips^®1.0

1.0

1.0 mg Fluorescein Sodium
Ophthalmic Strips USP
300 Sterile Strips

GloStrips Fluorescein Sodium STRIP Product Information Product Type Human prescription drug label Item Code (Source) NDC:51801-009 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUORESCEIN SODIUM FLUORESCEIN 1 mg Product Characteristics Color Size Shape ORANGE (paper is white and tip is orange) 52 mm RECTANGLE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 POUCH 2 1 in 1 POUCH 3 NDC:51801-009-40 100 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 2013-07-30