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Bioglo Ophthalmic Strip

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.

Product Facts

Each sterile strip is impregnated with 1 mg. of fluorescein sodium U.S.P.

INDICATIONS:

For staining the anterior segment of the eye when fitting contact lenses, in disclosing corneal injury and in applanation tonometry.

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DIRECTIONS FOR USE:

To insure full fluorescence and patient comfort, the BioGlo impregnated tip should be moistened before application. One or two drops of sterile irrigating or saline solution should be used for this purpose. Touch conjunctiva or fornix as required with moistened tip. 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:

Keep at room temperature.

NOTE:

For external use only. Contents may not be sterile if individual strips have been damaged or previously opened.

HOW SUPPLIED:

Dispenser carton containing 100 or 300 strips.

HUB Pharmaceuticals, LLC

Rancho Cucamonga, CA 91730

www.hubrx.com

Mfr. Lic. No. G/1197

European Representative:

Biovision Limited

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

Representative Packaging:

17238-900-99: BioGlo Individual Pouch (above)

17238-900-11: Dispenser Carton containing 100 strips (above)

17238-900-30: Dispenser Carton containing 300 strips (above)

BIOGLO 
fluorescein sodium strip
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17238-900
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUORESCEIN SODIUM (FLUORESCEIN) FLUORESCEIN SODIUM 1 mg  in 1 mg
Packaging
# Item Code Package Description
1 NDC:17238-900-11 100 PACKET in 1 BOX
1 NDC:17238-900-99 1 mg in 1 PACKET
2 NDC:17238-900-30 300 PACKET in 1 BOX
2 NDC:17238-900-99 1 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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