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 Laboratoires Thea, Similasan Corporation. 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)
  
• 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

Questions?

1-800-240-9780 or getinfo@similasanusa.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: 82095-700
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
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: 82095-700-05	5 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)

Registrant - Similasan Corporation (111566530)