IVIZIA LUBRICANT EYE FOR SEVERE NIGHT DRY EYES- povidone solution, gel forming / drops 
Laboratoires Thea

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.

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iVizia Lubricant Eye Gel for Severe Night Dry Eyes

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 15 minutes between using two different eye products. Use this gel last.
  • Do not use if you are allergic to any of the ingredients.
  • If solution changes color or becomes cloudy, do not use.
  • Do not use if the pouch or vial is damaged.
  • To avoid contamination, do not touch the tip of container to any surface. Do not reuse. Once opened, discard.
  • Store below 77°F. 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.

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:

Gel is particularly suited for severe dry eye or nighttime use.

  • 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.
  • 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.

Inactive Ingredients

Carbomer, Purified water, Sodium hyaluronate, Sodium hydroxide, Sorbitol, Trehalose

Questions?

1-800-240-9780 or getinfo@similasanusa.com.

Principle Display Panel

iVizia
Lubricant Eye Gel
For Severe/Night Dry Eyes
0.014 OZ (0.4g) each

30 sterile single-use vials

iVizia
Lubricant Eye Gel
For Severe/Night Dry Eyes
0.014 OZ (0.4g) each
30 sterile single-use vials

IVIZIA LUBRICANT EYE FOR SEVERE NIGHT DRY EYES 
povidone solution, gel forming / drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82095-701
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE2.5 mg  in 0.5 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL (UNII: 506T60A25R)  
TREHALOSE (UNII: B8WCK70T7I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82095-701-1230 in 1 CARTON11/05/2021
10.4 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01811/05/2021
Labeler - Laboratoires Thea (576949457)
Registrant - Similasan Corporation (111566530)

Revised: 6/2023
 
Laboratoires Thea