Ivizia Dry Eye
FDA Label NDC 82095-700

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Thea for the product Ivizia Dry Eye (NDC 82095-700). 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 ingredient, purpose, uses (one or more of these), warnings:, if pregnant, trying to get pregnant or breast feeding,, keep out of reach of children., when using this product, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 10 minutes between using two different eye products
  • Do not use if you are allergic to any of the ingredients.
  • If solution changes color or becomes cloudy, do not use.
  • To avoid contamination, do not touch the tip of container to any surface. Replace cap after using.
  • Use up to 90 days after opening. Store below 77°F. Do not use after the expiration date on the carton. 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.
  • After first use, if exposed to low atmospheric pressure, the bottle can leak.

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:

  • Wash hands well before use.
  • Instill 1 or 2 drops in the affected eye(s) as needed. Can be used when wearing contact lenses.
  • *To limit blurriness when using contact lenses: remove contacts, apply drops, then insert contacts.

Inactive Ingredients

Hydrochloric acid, purified water, sodium chloride, sodium hyaluronate, trehalose, tromethamine

Principle Display Panel

iVizia
Sterile Lubricant Eye Drops
For Dry Eyes
0.33 FL OZ (10ml)

Iviziasterile Lubricant Eye Dropsfor Dry Eyes0.33 Fl Oz (10ml) (Ivizia Dry Eye Drops 10ml 01)

Iviziasterile Lubricant Eye Dropsfor Dry Eyes0.33 Fl Oz (10ml) (Ivizia Dry Eye Drops 10ml 01)

* Please review the disclaimer below.