GLOSTRIPS- rose bengal sodium strip 
Nomax Inc.

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


Fig. 4

Figure

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

Principal Display Panel - 100 Strip Carton

GLOSTRIPS 
rose bengal sodium strip
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51801-004
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Rose Bengal Sodium (UNII: 956575SN5L) (Rose Bengal AT - UNII:1IID5XA5GB) Rose Bengal Sodium1.3 mg
Product Characteristics
ColorPINK, WHITEScore    
ShapeRECTANGLE (with tapered end) Size52mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51801-004-40100 in 1 CARTON08/20/2013
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER08/20/2013
Labeler - Nomax Inc. (103220273)
Establishment
NameAddressID/FEIBusiness Operations
Nomax Inc.103220273MANUFACTURE(51801-004)

Revised: 12/2019
Document Id: 77d8ad19-ba34-4cd0-9e87-acb2cb9d96b9
Set id: 4d5107c6-5077-4006-994f-1cd351775b80
Version: 3
Effective Time: 20191223
 
Nomax Inc.