ROSEGLO- rose bengal strip 
HUB Pharmaceuticals, 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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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.

HUB_RoseGlo Instructions for Opening Strip

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:

HUB_RoseGlo Strip

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

HUB_RoseGlo Box

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

ROSEGLO 
rose bengal strip
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17238-910
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSE BENGAL SODIUM (UNII: 956575SN5L) (ROSE BENGAL AT - UNII:1IID5XA5GB) ROSE BENGAL SODIUM1.5 mg  in 1.5 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17238-910-11100 in 1 BOX04/01/201204/01/2012
1NDC:17238-910-971.5 mg in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/201204/01/2012
Labeler - HUB Pharmaceuticals, Inc. (611747945)
Establishment
NameAddressID/FEIBusiness Operations
Contacare Ophthalmics & Diagnostics915821765manufacture(17238-910)

Revised: 5/2017
 
HUB Pharmaceuticals, Inc.