BIOGLO- fluorescein sodium 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.

----------

BIO GLO (fluorescein sodium) strip

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.

HUB_BioGlo Instructions For Opening Strips

  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

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:

HUB BioGlo Pouch

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

HUB BioGlo 100 Carton

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

HUB BioGlo 300 Carton

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

BIOGLO 
fluorescein sodium strip
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17238-900
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUORESCEIN SODIUM (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN SODIUM1 mg  in 1 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17238-900-11100 in 1 BOX04/01/2018
1NDC:17238-900-991 mg in 1 PACKET; Type 0: Not a Combination Product
2NDC:17238-900-30300 in 1 BOX04/01/2018
2NDC:17238-900-991 mg in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/2012
Labeler - HUB Pharmaceuticals, Inc. (611747945)
Establishment
NameAddressID/FEIBusiness Operations
OMNI LENS PRIVATE LIMITED862170057manufacture(17238-900)
Establishment
NameAddressID/FEIBusiness Operations
Madhu Instruments Pvt.Ltd.915827852manufacture(17238-900)

Revised: 12/2022
Document Id: efbb9715-e57b-d385-e053-2a95a90a40a6
Set id: f72b68c7-a52f-40df-a47d-8e2d8174091d
Version: 8
Effective Time: 20221213
 
HUB Pharmaceuticals, Inc.