GLOSTRIPS- fluorescein sodium strip

SPL UNCLASSIFIED SECTION

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.
SPL UNCLASSIFIED SECTION

Nomax, Inc. St. Louis, MO 63123 USA

Rev. 07/13
MSN 015-244

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.

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

INGREDIENTS AND APPEARANCE

GLOSTRIPS
fluorescein sodium strip

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Fluorescein Sodium (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR)	FLUORESCEIN	1 mg

Product Characteristics
Color	ORANGE (paper is white and tip is orange)	Score
Shape	RECTANGLE (with tapered end)	Size	52mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 51801-009-50	300 in 1 CARTON	07/30/2013
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 51801-009-40	100 in 1 CARTON	07/30/2013
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		07/30/2013

Labeler - Nomax Inc. (103220273)

Name	Address	ID/FEI	Business Operations
Establishment
Nomax Inc.		103220273	MANUFACTURE(51801-009)

Mark Image Registration \| Serial	Company Trademark Application Date
GLOSTRIPS 78139112 2760506 Live/Registered	Amcon Laboratories, Inc. 2002-06-26