NDC 53799-700 Ivizia Dry Eye

Povidone

NDC Product Code 53799-700

NDC 53799-700-13

Package Description: 5 mL in 1 BOTTLE, DROPPER

NDC Product Information

Ivizia Dry Eye with NDC 53799-700 is a a human over the counter drug product labeled by Similasan Ag. The generic name of Ivizia Dry Eye is povidone. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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 Dry Eye 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.

  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • TREHALOSE (UNII: B8WCK70T7I)
  • TROMETHAMINE (UNII: 023C2WHX2V)

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 Ag
Labeler Code: 53799
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: 09-30-2021 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 Dry Eye 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 10 minutes between using two different eye productsDo 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 [email protected]

Principle Display Panel

IViziaSterile Lubricant Eye DropsFor Dry Eyes0.16 FL OZ (5ml)

* Please review the disclaimer below.