FDA Label for Ivizia Lubricant Eye For Severe Night Dry Eyes

View Indications, Usage & Precautions

Ivizia Lubricant Eye For Severe Night Dry Eyes Product Label

The following document was submitted to the FDA by the labeler of this product Similasan Corporation. 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 Ingredient



Povidone 0.5%


Purpose



Eye lubricant


Uses



(one or more of these)

  • For the temporary relief of burning and irritation due to dryness of the eye
  • For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind and sun
  • For use as a protectant against further irritation or to relieve dryness of the eye
  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Warnings:



  • For external use only (in the eye)
  • Wait at least 15 minutes between using two different eye products. Use this gel last.
  • Do not use if you are allergic to any of the ingredients.
  • If solution changes color or becomes cloudy, do not use.
  • Do not use if the pouch or vial is damaged.
  • To avoid contamination, do not touch the tip of container to any surface. Do not reuse. Once opened, discard.
  • Store below 77°F. Expiration date refers to the product in intact packaging, stored correctly.
  • 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, Trying To Get Pregnant Or Breast Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


When Using This Product



  • Rare possibility of mild eye irritation and ocular redness. In such cases, contact lens wearers should remove their contact lenses.
  • You might experience bothersome symptoms such as a burning sensation, stinging sensation, foreign body sensation in the eye and blurred vision for a short time.

Directions:



Gel is particularly suited for severe dry eye or nighttime use.

  • Wash hands well before use.
  • Take one single-use vial off the strip. Turn upside down, tap the vial and twist off the top.
  • Instill 1 or 2 drops in the affected eye(s) as needed.
  • If you wear contact lenses: you must remove them before using iVIZIA gel. After use wait at least 30 minutes before putting your lenses back in.

Inactive Ingredients



Carbomer, Purified water, Sodium hyaluronate, Sodium hydroxide, Sorbitol, Trehalose


Questions?



1-800-240-9780 or [email protected].


Principle Display Panel



iVizia
Lubricant Eye Gel
For Severe/Night Dry Eyes
0.014 OZ (0.4g) each

30 sterile single-use vials


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