Label: IVIZIA DRY EYE- povidone solution/ drops
-
Contains inactivated NDC Code(s)
NDC Code(s): 82095-700-11 - Packager: Laboratoires Thea
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 29, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
-
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.
- For the temporary relief of burning and irritation due to 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.
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.
-
For external use only (in the eye)
- Directions:
- Inactive Ingredients
- Questions?
- Principle Display Panel
-
INGREDIENTS AND APPEARANCE
IVIZIA DRY EYE
povidone solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82095-700 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE 50 mg in 10 mL Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID (UNII: QTT17582CB) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TREHALOSE (UNII: B8WCK70T7I) TROMETHAMINE (UNII: 023C2WHX2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82095-700-11 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 11/29/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 11/29/2021 Labeler - Laboratoires Thea (576949457)