GLOSTRIPS - fluorescein sodium strip 
Nomax Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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GloStrips® 1.0

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®

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

Figure 3
3.

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

Figure 4

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

PRINCIPAL DISPLAY PANEL - 300 Strip Carton
GLOSTRIPS  
fluorescein sodium strip
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51801-009
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fluorescein Sodium (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN1 mg
Product Characteristics
ColorORANGE (paper is white and tip is orange) Score    
ShapeRECTANGLE (with tapered end) Size52mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51801-009-50300 in 1 CARTON07/30/2013
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:51801-009-40100 in 1 CARTON07/30/2013
21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER07/30/2013
Labeler - Nomax Inc. (103220273)
Establishment
NameAddressID/FEIBusiness Operations
Nomax Inc.103220273MANUFACTURE(51801-009)

Revised: 12/2019
Document Id: be8f6626-961d-48c3-ba7f-a2fae87c4cb6
Set id: d06a4432-c76c-4e2a-abec-6bc5b4e82d51
Version: 2
Effective Time: 20191223
 
Nomax Inc.