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GloStrips

Pronunciation

Generic Name: fluorescein sodium
Dosage Form: ophthalmic strip

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.

GloStrips®

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 is GloStrips Supplied

Dispenser carton containing 100 sterile strips.

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

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) Rose Bengal Sodium 1.3 mg
Product Characteristics
Color PINK, WHITE Score     
Shape RECTANGLE (with tapered end) Size 52mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51801-004-40 100 POUCH in 1 CARTON
1 1 STRIP in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/20/2013
Labeler - Nomax Inc. (103220273)
Establishment
Name Address ID/FEI Operations
Nomax Inc. 103220273 MANUFACTURE(51801-004)
Revised: 08/2013
 
Nomax Inc.



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