C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS- fluorescein sodium strip

C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips by

Drug Labeling and Warnings

C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips by is a Prescription medication manufactured, distributed, or labeled by Vistamerica USA, Madhu Instruments Pvt.Ltd., Wizcure Pharmaa 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:

Intended for use when fitting contact lenses.

DIRECTIONS FOR USE:

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 taking care to touch only the white portion of the strip

STORAGE:

Store at 10 oC - 30 oC.

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 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:

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

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

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

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

INGREDIENTS AND APPEARANCE

C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS 
fluorescein sodium strip

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83851-100
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: 83851-100-10	100 in 1 BOX	10/01/2024
1		1 mg in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 83851-100-30	300 in 1 BOX	10/01/2024
2		1 mg in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 83851-100-05	50 in 1 BOX	10/01/2024
3		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		10/01/2024

Labeler - Vistamerica USA (122342378)

Establishment
Name	Address	ID/FEI	Business Operations
Madhu Instruments Pvt.Ltd.		915827852	manufacture(83851-100)

Establishment
Name	Address	ID/FEI	Business Operations
Wizcure Pharmaa Pvt. Ltd.		871769521	manufacture(83851-100)