IVIZIA DRY EYE- povidone solution/ 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 Dry Eye Drops 5ml

Active Ingredient

Povidone 0.5%

Purpose

Eye lubricant

Uses (one or more of these)

Warnings:

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:

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)

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

IVIZIA DRY EYE 
povidone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82095-700
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TREHALOSE (UNII: B8WCK70T7I)  
TROMETHAMINE (UNII: 023C2WHX2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82095-700-055 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/29/2021
Labeler - Laboratoires Thea (576949457)
Registrant - Similasan Corporation (111566530)

Revised: 11/2021
Document Id: f0c03a5e-8ef0-4578-a4ac-bf224b16490e
Set id: b7c35b19-848d-457b-bb8c-2c0af6027ad2
Version: 1
Effective Time: 20211129
 
Laboratoires Thea