Label: IVIZIA DRY EYE- povidone solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 consumer or patient please visit this version.

  • 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)

    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 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)