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Roseglo Ophthalmic Strip

Generic Name: rose bengal
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.

Product Facts

Each sterile strip is impregnated with 1.5 mg. of Rose Bengal.

Rose Bengal is a vital stain that stains dead or degenearate epithelial cells of the cornea and conjunctiva.

INDICATIONS:

For use as a diagnostic agent when superficial corneal or conjunctival tissue change is suspected.

DIRECTIONS FOR USE:

To obtain optimal staining and patient comfort, the Rose Glo impregnated tip should be moistened before application with one or two drops of sterile irrigating or saline solution. Apply moistened tip to conjunctiva or fornix as required. It is recommended that the patient blink several times after application.

1. Hold package in middle and tear down toward sterile strip

2. Turn over and tear down from other side, taking care not to tear the sterile strip.

3. Grasp each end of package firmly as shown, without touching the sterile strip, and pull apart.

STORAGE:

Store at room temperature.

NOTE:

For external use only. Contents may not be sterile if the individual strip package has been damaged or previously opened. Keep out of the reach of childred.

HOW SUPPLIED:

Dispenser carton containing 100 strips.

HUB Pharmaceuticals, LLC

Rancho Cucamonga, CA 91730

www.hubrx.com

GUJ/DRUG/G-1197

European Representative:

Biovision Limited

Wayside, Tring Road, Wellhead, Dunstable, BEDS LU6 2JU, UK

Representative Packaging:

17238-910-97: RoseGlo individual Strip (above)

17238-910-11: Dispenser Carton containing 100 strips (above)

ROSEGLO 
rose bengal strip
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17238-910
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 1.5 mg  in 1.5 mg
Packaging
# Item Code Package Description
1 NDC:17238-910-11 100 PACKET in 1 BOX
1 NDC:17238-910-97 1.5 mg in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/2012
Labeler - HUB Pharmaceuticals, Inc. (611747945)
Establishment
Name Address ID/FEI Operations
Contacare Ophthalmics & Diagnostics 915821765 manufacture
Revised: 04/2012
 
HUB Pharmaceuticals, Inc.



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