Goniovisc
FDA Label NDC 17238-610

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, Llc for the product Goniovisc (NDC 17238-610). 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 active ingredients:, uses:, indications & usage:, warnings:, when using this product, stop use and ask a physician, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Active Ingredients             Purpose

Hypromellose 25 mg (2.5%)......Lubricant

Uses:

  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
  • For use in the eyes only.

Indications & Usage:

For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Warnings:

  • For external use only.
  • Do not use if sealed bottle tip is broken or punctured.
  • If solution changes color or becomes cloudy, do not use.

When Using This Product

  • To avoid contamination, do not touch tip of container to any surface.

  • Replace cap after using.

Stop Use And Ask A Physician

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information:

  • Store at room temperature 15°-30°C (59°-86°F).
  • Do not freeze.
  • Keep box for complete information.

Inactive Ingredients:

Inactive Ingredients:

  • Boric Acid
  • Edetate Disodium
  • Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.0-7.8)

  • Sodium Borate

  • Water for Injection

    • Preservative:

    • Benzalkonium Chloride Solution NF 0.02% v/v

Questions?

1-800-Eye-Drop (393-3767)

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