FDA.reportPublic FDA data

iVizia Dry Eye Drops 5ml Sample

Manufacturer
Similasan AG
Effective date
2021-09-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:42:33

Label at a glance#

ProductiVizia Dry Eye
Active ingredientPOVIDONE
Label structure8 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone 0.5%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

(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:

WARNINGS SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

When using this product

OTC - WHEN USING SECTION

  • 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:

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

Hydrochloric acid, purified water, sodium chloride, sodium hyaluronate, trehalose, tromethamine

Questions?

OTC - QUESTIONS SECTION

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

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2586186iVIZIA 0.5 % Ophthalmic SolutionPSN2
2570860povidone 0.5 % Ophthalmic SolutionPSN2
2586186povidone 5 MG/ML Ophthalmic Solution [iVizia]SBD2
2570860povidone 5 MG/ML Ophthalmic SolutionSCD2
2586186iVizia 0.5 % Ophthalmic SolutionSY2
2586186iVizia 5 MG/ML Ophthalmic SolutionSY2
2570860povidone 0.5 % Ophthalmic SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-700-132023-01-30C16284748780-1f386c64a-19bd-0266-e053-dadaa90a7c1aiVizia Dry Eye Drops 5ml Sample

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-700-13iVizia Dry Eye5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-700IVIZIA DRY EYE (POVIDONE) SOLUTION/ DROPS [SIMILASAN AG]2Legacy NDC, 1 package rows20211001_25787325-c4e9-4cb1-bbc8-6cd3da18af0f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53799-70053799-700-13
81372-700

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONEFZ989GH94EACTIB
HYDROCHLORIC ACIDQTT17582CBIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYALURONATE SODIUMYSE9PPT4THIACT
TREHALOSEB8WCK70T7IIACT
TROMETHAMINE023C2WHX2VIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e362829d-9f3d-47e4-9a06-9833c9e1a66625787325-c4e9-4cb1-bbc8-6cd3da18af0f2021-09-17WarningsExact identifier
spl id: e362829d-9f3d-47e4-9a06-9833c9e1a666
spl set id: 25787325-c4e9-4cb1-bbc8-6cd3da18af0f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.