C20h10na2o5 Fluorescein Sodium Ophthalmic Strips Strip
FDA Label NDC 83851-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vistamerica Usa for the product C20h10na2o5 Fluorescein Sodium Ophthalmic Strips (NDC 83851-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding product facts, indications:, directions for use:, storage:, note:, otc - keep out of reach of children, how supplied:, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

How Supplied:

Dispenser carton containing 50, 100, or 300 strips.

Other

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

Vistamerica USA

20 Perkins Dr, Prescott

AZ 86301

Representative Packaging:

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

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

* Please review the disclaimer below.