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  5. Label Information: Goniovisc Ophthalmic Lubricant

FDA Label for Goniovisc Ophthalmic Lubricant

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. USES:
    3. INDICATIONS & USAGE:
    4. WARNINGS:
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A PHYSICIAN
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS:
    10. OTHER INFORMATION:
    11. INACTIVE INGREDIENTS:
    12. QUESTIONS?
    13. PACKAGE LABELS:

Goniovisc Ophthalmic Lubricant Product Label

The following document was submitted to the FDA by the labeler of this product Hub Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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