IVIZIA DRY EYE- povidone solution/ drops

iVIZIA Dry Eye by

Drug Labeling and Warnings

iVIZIA Dry Eye by is a Otc medication manufactured, distributed, or labeled by Thea Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

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 info@ivizia.com

Principle Display Panel

iVizia
Sterile Lubricant Eye Drops
For Dry Eyes
0.16 FL OZ (5ml)

INGREDIENTS AND APPEARANCE

IVIZIA DRY EYE 
povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82584-700
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	25 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TREHALOSE (UNII: B8WCK70T7I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TROMETHAMINE (UNII: 023C2WHX2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82584-700-05	1 in 1 CARTON	12/01/2024
1		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 82584-700-11	1 in 1 CARTON	12/01/2024
2		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 82584-700-13	1 in 1 CARTON	12/01/2024
3		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	12/01/2024

Labeler - Thea Pharma Inc. (117787029)