BIOGLO- fluorescein sodium strip

BioGlo by

Drug Labeling and Warnings

BioGlo by is a Prescription medication manufactured, distributed, or labeled by HUB Pharmaceuticals, Inc., OMNI LENS PRIVATE LIMITED, Madhu Instruments Pvt.Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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. Grasp tabs between thumbs & index fingers
2. Gently pull tabs apart
3. Remove strip taking care to touch only the white portion of the strip

STORAGE:

Keep at room temperature.

NOTE:

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

HOW SUPPLIED:

Dispenser carton containing 100 or 300 strips.

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

BIOGLO 
fluorescein sodium strip

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 17238-900
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUORESCEIN SODIUM (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR)	FLUORESCEIN SODIUM	1 mg  in 1 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17238-900-11	100 in 1 BOX	04/01/2018
1	NDC: 17238-900-99	1 mg in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 17238-900-30	300 in 1 BOX	04/01/2018
2	NDC: 17238-900-99	1 mg in 1 PACKET; Type 0: Not a Combination Product

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	Business Operations
OMNI LENS PRIVATE LIMITED		862170057	manufacture(17238-900)

Establishment
Name	Address	ID/FEI	Business Operations
Madhu Instruments Pvt.Ltd.		915827852	manufacture(17238-900)