Product Facts
Each sterile strip is impregnated with 1 mg. of fluorescein sodium U.S.P.
Bioglo
FDA Label NDC 17238-900
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hub Pharmaceuticals, Inc. for the product Bioglo (NDC 17238-900). 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:, how supplied:, representative packaging:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications:
For staining the anterior segment of the eye when fitting contact lenses, in disclosing corneal injury and in applanation tonometry.
Directions For Use:
To insure full fluorescence and patient comfort, the BioGlo 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.
1. Hold package in middle and tear down toward sterile strip
2. Turn over and tear down from other side, taking care not to tear the sterile strip.
3. Grasp each end of package firmly as shown, without touching the sterile strip, and pull apart.
Storage:
Keep at room temperature.
Note:
For external use only. Contents may not be sterile if individual strips have been damaged or previously opened.
How Supplied:
Dispenser carton containing 100 or 300 strips.
Representative Packaging:
17238-900-99: BioGlo Individual Pouch (above)
17238-900-11: Dispenser Carton containing 100 strips (above)
17238-900-30: Dispenser Carton containing 300 strips (above)
* Please review the disclaimer below.
