Fluorescein Sodium Ophthalmic Strips

Fluorescein Sodium Ophthalmic Strips
SPL v2
SPL
SPL Set ID 292abb69-84ad-4f61-e063-6394a90a1447
Route
OPHTHALMIC
Published
Effective Date 2025-06-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluorescein (1 mg)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-10-01

Description

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

How Supplied

Dispenser carton containing 50, 100, or 300 strips.


Medication Information

How Supplied

Dispenser carton containing 50, 100, or 300 strips.

Description

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

Note:

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

Section 42229-5

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

Section 50565-1

Keep out of reach of children

Storage:

Store at 10 oC - 30 oC.

Indications:

Intended for use when fitting contact lenses.

How Supplied:

Dispenser carton containing 50, 100, or 300 strips.

Product Facts

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

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

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)


Structured Label Content

Note: (NOTE:)

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

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children

Storage: (STORAGE:)

Store at 10 oC - 30 oC.

Indications: (INDICATIONS:)

Intended for use when fitting contact lenses.

How Supplied: (HOW SUPPLIED:)

Dispenser carton containing 50, 100, or 300 strips.

Product Facts

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

Directions for Use: (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

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)


Advanced Ingredient Data


Raw Label Data

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