C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips

Manufacturer
Vistamerica USA | Madhu Instruments Pvt.Ltd. | Wizcure Pharmaa Pvt. Ltd.
Effective date
2025-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 21:36:05

Label at a glance#

ProductC20H10Na2O5 Fluorescein Sodium Ophthalmic Strips
Active ingredientFLUORESCEIN SODIUM
Label structure9 sections

Dosage and administration

To insure full fluorescence and patient comfort, the 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 strip takin...

Storage and handling

Store at 10 o C - 30 o C.

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

Intended for use when fitting contact lenses.

DIRECTIONS FOR USE:

INDICATIONS & USAGE SECTION

To insure full fluorescence and patient comfort, the 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.

83851-100: Vista Fluroescein Sodium83851-100: Vista Fluroescein Sodium

Grasp tabs between thumbs & index fingers

Gently pull tabs apart

Remove strip taking care to touch only the white portion of the strip

STORAGE:

STORAGE AND HANDLING SECTION

Store at 10 oC - 30 oC.

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 50, 100, or 300 strips.

SPL UNCLASSIFIED SECTION

Manufactured by:

Madhu Instruments Pvt. Ltd.

A-260, Okhla Industrial Area, Phase-1, New Delhi-110 020 India

DUNS number - 91-582-7852

M.L.: S(0116)/MB/18

and

Wizcure Pharmaa Pvt. Ltd.

H-881, Phase 3

RIICO Industrial Area

Bhiwadi-301019, India

DUNS Number: 87-176-9521

Imported and distributed by:

Vistamerica USA

20 Perkins Dr, Prescott

AZ 86301

Representative Packaging:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83851-100: Fluorescein Sodium Ophthalmic Pouch (Wizcure)83851-100: Fluorescein Sodium Ophthalmic Pouch (Wizcure)

83851-100: Fluorescein Sodium Ophthalmic Strip Individual Pouch (Wizcure) (above)

83851-100: Fluorescein Sodium Ophthalmic Strip Box (Wizcure)83851-100: Fluorescein Sodium Ophthalmic Strip Box (Wizcure)

83851-100: Fluorescein Sodium Ophthalmic Strip Box (Wizcure) (above)

83851-100: Fluorescein Sodium Ophthalmic Strip How Used (above)83851-100: Fluorescein Sodium Ophthalmic Strip How Used (above)

83851-100: Fluorescein Sodium How Used (above) 83851-100: Fluorescein Sodium Ophthalmic Strip Box (above)83851-100: Fluorescein Sodium Ophthalmic Strip Box (above)83851-100: Fluorescein Sodium Ophthalmic Strip Box (above)

Vista Fluorescein Sodium Ophthalmic Strip (Individual Pouch) 83851-100Vista Fluorescein Sodium Ophthalmic Strip (Individual Pouch) 83851-100

83851-100: Fluorescein Sodium Ophthalmic Strip Individual Pouch (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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83851-100-05C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips50 in 1 BOXSTRIP502
83851-100-05C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips1 mg in 1 PACKETSTRIP12
83851-100-10C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips100 in 1 BOXSTRIP1002
83851-100-10C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips1 mg in 1 PACKETSTRIP12
83851-100-30C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips300 in 1 BOXSTRIP3002
83851-100-30C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips1 mg in 1 PACKETSTRIP12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83851-100-30EA - Each83851-100abd99e11-a506-45fb-affc-00160498546412025-07-08

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
83851-10083851-100-10, 83851-100-30, 83851-100-05

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
C20H10Na2O5 Fluorescein Sodium Ophthalmic StripsFLUORESCEIN SODIUMVistamerica USA292abb69-84ad-4f61-e063-6394a90a14472025-06-01Exact identifier
ndc (package): 83851-100-30
ndc (package): 83851-100-10
ndc (package): 83851-100-05
ndc (product): 83851-100
ndc11 (package): 83851010030
ndc11 (package): 83851010010
ndc11 (package): 83851010005
spl id: 386aaf96-81c0-bd6f-e063-6394a90ad761
spl set id: 292abb69-84ad-4f61-e063-6394a90a1447

Reported adverse events (FAERS/openFDA)#

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