FDA.reportPublic FDA data

BioGlo

Manufacturer
HUB Pharmaceuticals, Inc. | OMNI LENS PRIVATE LIMITED | Madhu Instruments Pvt.Ltd.
Effective date
2024-01-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 20:57:49

Label at a glance#

ProductBioGlo
Active ingredientFLUORESCEIN SODIUM
Label structure9 sections

Dosage and administration

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. Grasp tabs between thumbs & index fingers Gently pull tabs apart Remove stri...

Storage and handling

Keep at room temperature.

Label contents#

Full prescribing information#

Product Facts

SPL UNCLASSIFIED SECTION

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

INDICATIONS:

INDICATIONS & USAGE SECTION

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

DIRECTIONS FOR USE:

INDICATIONS & USAGE SECTION

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 StripsHUB_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:

STORAGE AND HANDLING SECTION

Keep at room temperature.

NOTE:

SPL UNCLASSIFIED SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

HOW SUPPLIED:

HOW SUPPLIED SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HUB BioGlo PouchHUB BioGlo Pouch

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

HUB BioGlo 100 CartonHUB BioGlo 100 Carton

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

HUB BioGlo 300 CartonHUB BioGlo 300 Carton

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

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FLUORESCEIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f43a274-9585-47cb-b427-0eb3e578384dProduct name120250623
4a998fa9-995e-4ea5-97ef-93a559305758Product name120200706
c94ccba7-2a03-4a3e-a891-d62a57340fb2Product name120180215

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17238-900-112026-01-29C16284748780-149896155-afd0-586f-e063-e6dba90add90BIO GLO (fluorescein sodium) strip
17238-900-302026-01-29C16284748780-149896155-afd0-586f-e063-e6dba90add90BIO GLO (fluorescein sodium) strip

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17238-900-11BioGlo100 in 1 BOXSTRIP1009
17238-900-30BioGlo300 in 1 BOXSTRIP3009
17238-900-99BioGlo1 mg in 1 PACKETSTRIP19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17238-900BIOGLO (FLUORESCEIN SODIUM) STRIP [HUB PHARMACEUTICALS, INC.]9Legacy NDC, 3 package rows20240110_f72b68c7-a52f-40df-a47d-8e2d8174091d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17238-900-11EA - Each17238-900c6b6698b-88c1-4277-96a0-8c949c7b8b1512012-07-24
17238-900-30EA - Each17238-90033463b16-cbce-4a9a-a98b-0732164f8ffb12012-07-24
17238-900-99EA - Each17238-90031a423b7-192d-4b1a-887c-6379ee2b657112023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FLUORESCEIN SODIUMACTIVE INGREDIENT93X55PE38X1
FLUORESCEINACTIVE MOIETYTPY09G7XIR1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17238-90017238-900-99, 17238-900-11, 17238-900-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
FLUORESCEIN SODIUM93X55PE38XACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e86525e-501b-e995-e063-6294a90a4d9cf72b68c7-a52f-40df-a47d-8e2d8174091d2024-01-01Exact identifier
spl id: 0e86525e-501b-e995-e063-6294a90a4d9c
spl set id: f72b68c7-a52f-40df-a47d-8e2d8174091d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.