Active Ingredient
Povidone 0.5%
Ivizia Lubricant Eye Gel
FDA Label NDC 82584-701
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Thea Pharma Inc. for the product Ivizia Lubricant Eye Gel (NDC 82584-701). 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, warnings:, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - when using, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
Do not use if:
• you are allergic to any of the ingredients.
• solution changes color or becomes cloudy.
• pouch or vial is damaged or broken
• To avoid contamination, do not touch the tip of container to any surface. Do not reuse. Once opened, discard.
• 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.
Otc - Pregnancy Or Breast Feeding
If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
When using this product:
• Rare possibility of mild eye irritation and ocular redness. In such cases, contact lens wears should remove their contact lenses.
• You might experience bothersome symptoms such as burning sensation, stinging sensation, foreign body sensation in the eye and blurred vision for a short time.
Directions
• 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. Gel is particularly suited for severe dry eye or nighttime use.
• Wait at least 15 minutes between using two different eye products. Use this gel last.
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.
Other Information
Store below 86°F. Expiration date refers to the product in intact packaging, stored correctly.
Inactive Ingredients
Carbomer, Purified water, Sodium hyaluronate, Sodium hydroxide, Sorbitol, Trehalose
Questions?
1-833-838-4028 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
Principle Display Panel (Image1)
* Please review the disclaimer below.
