FUL-GLO

Manufacturer
Akorn
Effective date
2022-09-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 20:43:38

Label at a glance#

ProductFUL-GLO
Active ingredientFluorescein Sodium
Label structure7 sections

Dosage and administration

To ensure full fluorescence and patient comfort, the Ful-Glo impregnated tip should be moistened before application. One or two drops of sterile irrigation 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. NOTE: Contents may not be sterile if individual strip package has been damaged or pre...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Diagnostic Agent For Professional Use Only

SPL UNCLASSIFIED SECTION

Each sterile strip is impregnated with 0.6 mg of fluorescein sodium USP.

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:

DOSAGE & ADMINISTRATION SECTION

To ensure full fluorescence and patient comfort, the Ful-Glo impregnated tip should be moistened before application. One or two drops of sterile irrigation 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.

NOTE: Contents may not be sterile if individual strip package has been damaged or previously opened. Store below 30°C.

INSTRUCTIONS FOR OPENING STERILE STRIPS:

INFORMATION FOR PATIENTS SECTION

1. Separate tab ends. Pull apart slowly until white handle visible. Remove from envelope.

Fig. 1
Fig. 1

Or, for a convenient handle protector-

2. Grasp envelope firmly with two hands as shown in Fig. 2. Tear down the middle of envelope to strip.

Fig. 2
Fig. 2

Hold the handle end of the strip firmly in the right hand as shown in Fig 3. Hold left edge of paper envelope so that tip is not held between the fingers.

Fig. 3
Fig. 3

Snap the left portion off quickly. Strip is ready to use with a convenient handle protector.

Fig. 4
Fig. 4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-403-03 ONE STERILE STRIP

FUL-GLO® Fluorescein Sodium

Sterile Ophthalmic Strips 0.6 mg

Contents may not be sterile if this package has been damaged or

previously opened. See box for complete information.

Principal Display Panel Text for Container Label
Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-403-03

FUL-GLO®

Fluorescein Sodium

Ophthalmic Strips, USP

0.6 mg

Diagnostic Agent for Professional Use Only

300 Sterile Strips

Akorn Logo

Principal Display Panel Text for Carton Label
Principal Display Panel Text for Carton Label

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-403-03FUL-GLO300 in 1 CARTONSTRIP3007
17478-403-03FUL-GLO1 in 1 APPLICATORSTRIP17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-403FUL-GLO (FLUORESCEIN SODIUM) STRIP [AKORN]7Legacy NDC, 2 package rows20220914_88ced9b3-60af-492b-9aca-1046efed17cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-403-03EA - Each17478-403320bea66-c4d2-4928-ae54-ee157ffbeff712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
D&C YELLOW NO. 8ACTIVE 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
17478-40317478-403-03

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

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
25d8592a-586c-417a-92bd-44b7f1b6d58688ced9b3-60af-492b-9aca-1046efed17cb2022-09-12Exact identifier
spl id: 25d8592a-586c-417a-92bd-44b7f1b6d586
spl set id: 88ced9b3-60af-492b-9aca-1046efed17cb

Reported adverse events (FAERS/openFDA)#

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