Active Ingredient
Povidone 0.5%
Ivizia Dry Eye Solution/ Drops
FDA Label NDC 82584-700
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Thea Pharma Inc. for the product Ivizia Dry Eye (NDC 82584-700). 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, warnings, keep out of reach of children., when using this product, directions:, other information, 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.
• To avoid contamination, do not touch the tip of container to any surface.
Replace cap after using.
• 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.
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.
Twist cap counterclockwise to break tamper evident seal.
Press firmly on bottle sides. Dispensing drops is slower due to preservative-free filter.
Dispense 1-2 drops in the affected eye as needed.
Safe with contacts. *To limit blurriness when using contact lenses: remove contacts, apply drops, then insert contacts.
Other Information
• 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.
• After first use, if exposed to low atmospheric pressure, the bottle can drip.
Inactive Ingredients
Purified water, sodium chloride, sodium hyaluronate, trehalose, tromethamine. May contain hydrochloric acid to adjust pH.
Questions?
1-833-838-4028 or [email protected]
Principle Display Panel
iVizia
Sterile Lubricant Eye Drops
For Dry Eyes
0.16 FL OZ (5ml)
Principle Display Panel (Image1)
* Please review the disclaimer below.
