NDC 79892-301 Surewell Sanitizing Wipes

Alcohol, Glyceryl Laurate, Sodium Levulinate, Laurylpyridinium Chloride, Caprylhydroxamic Acid

NDC Product Code 79892-301

NDC CODE: 79892-301

Proprietary Name: Surewell Sanitizing Wipes What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Alcohol, Glyceryl Laurate, Sodium Levulinate, Laurylpyridinium Chloride, Caprylhydroxamic Acid What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 79892 - Ifons Corp.

NDC 79892-301-01

Package Description: 90 g in 1 POUCH

NDC Product Information

Surewell Sanitizing Wipes with NDC 79892-301 is a a human over the counter drug product labeled by Ifons Corp.. The generic name of Surewell Sanitizing Wipes is alcohol, glyceryl laurate, sodium levulinate, laurylpyridinium chloride, caprylhydroxamic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Ifons Corp.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Surewell Sanitizing Wipes 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.

  • ALCOHOL 3 g/100g
  • GLYCERYL LAURATE 6 g/100g
  • CAPRYLHYDROXAMIC ACID 4 g/100g

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.

  • LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL)
  • SODIUM LEVULINATE (UNII: VK44E1MQU8)
  • COCOTRIMONIUM CHLORIDE (UNII: KB94658IHQ)
  • LEVULINIC ACID (UNII: RYX5QG61EI)
  • WATER (UNII: 059QF0KO0R)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Ifons Corp.
Labeler Code: 79892
FDA Application Number: part333A 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 08-22-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Surewell Sanitizing Wipes Product Label Images

Surewell Sanitizing Wipes 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

ALCOHOL, GLYCERYL LAURATE, SODIUM LEVULINATE, LAURYLPYRIDINIUM CHLORIDE, CAPRYLHYDROXAMIC ACID

Purpose

ANTIMICROBIAL

Direction

Open cover, pull needed number of sheets, reseal after each use.

Do Not Use

Do not use: Do not apply it on skin where you have eczema, wounded, irritated.storage and cautions for handling

A) Avoid storing under direct sunlight, hot and cool place.

B) keep the sticker or stopper closed after use.

C) Do not throw in the flush toilet it. because it may be clogged if it is thrown away in the flush toilet

D) If wet tissue put back into the package with contaminated hands, it may be deteriorated.

recommended to use within 1 month of opening.

Stop Use And Ask A Doctor,

If anyone of following symptoms such as red spot, swollenness and/or itching, occurs when using cosmetics, or symptoms appear by direct sunlight. stop using it and consult a doctor immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indication

Place enough product on hands to cover all surfaces. Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive

Water, Methylpropanediol, Sodium coco pg-dimonium chloride phosphate, Levulinic acid

Label

79892-301-01

* Please review the disclaimer below.