NDC 59262-701 Ivizia Lubricant Eye For Severe Night Dry Eyes

Povidone

NDC Product Code 59262-701

NDC 59262-701-12

Package Description: 30 VIAL, SINGLE-USE in 1 CARTON > .4 g in 1 VIAL, SINGLE-USE

NDC Product Information

Ivizia Lubricant Eye For Severe Night Dry Eyes with NDC 59262-701 is a a human over the counter drug product labeled by Similasan Corporation. The generic name of Ivizia Lubricant Eye For Severe Night Dry Eyes is povidone. The product's dosage form is solution, gel forming / drops and is administered via ophthalmic form.

Dosage Form: Solution, Gel Forming / Drops - A solution, which after usually being administered in a drop-wise fashion, forms a gel.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ivizia Lubricant Eye For Severe Night Dry Eyes Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • WATER (UNII: 059QF0KO0R)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITOL (UNII: 506T60A25R)
  • TREHALOSE (UNII: B8WCK70T7I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Similasan Corporation
Labeler Code: 59262
FDA Application Number: part349 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-14-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Ivizia Lubricant Eye For Severe Night Dry Eyes Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 eyeFor the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind and sunFor use as a protectant against further irritation or to relieve dryness of the eyeFor 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 [email protected]

Principle Display Panel

IViziaLubricant Eye GelFor Severe/Night Dry Eyes0.014 OZ (0.4g) each30 sterile single-use vials

* Please review the disclaimer below.