NDC 78740-006 Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack

Benzalkonium Chloride

NDC Product Code 78740-006

NDC CODE: 78740-006

Proprietary Name: Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack 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: Benzalkonium Chloride 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

  • 78740 - Ivresse Internacional, S.a. De C.v.
    • 78740-006 - Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack

NDC 78740-006-10

Package Description: 10 PATCH in 1 POUCH > 5 mL in 1 PATCH

NDC Product Information

Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack with NDC 78740-006 is a a human over the counter drug product labeled by Ivresse Internacional, S.a. De C.v.. The generic name of Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Ivresse Internacional, S.a. De C.v.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack 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.

  • BENZALKONIUM CHLORIDE 1.3 mg/mL

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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • TRISODIUM NITRILOTRIACETATE (UNII: E3C8R2M0XD)
  • WATER (UNII: 059QF0KO0R)

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: Ivresse Internacional, S.a. De C.v.
Labeler Code: 78740
FDA Application Number: part333E 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: 09-02-2020 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.

Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack Product Label Images

Ivresse Sanitizer Wet Wipes Antibacterial Travel Pack 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

Benzalkonium chloride 0.13% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Do Not Use

  • In children less than 2 months of age on open skin wounds

When Using This Product

Keep out eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor

If irritation or rash occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

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

Directions

  • Place enough product to cover all surfaces. Rub hands together until dry.supervise children under 6 years of age when use this product to avoid swallwoing

Other Information

  • Store between 68-77°F (20-25°C)do not expose to excessive heat TAMPER EVIDENT:Do not use if the sealable tab is open or torn.

Inactive Ingredients

Allantoin, benzyl alcohol, edetate sodium, fragrance, glycerin, phenoxyethanol, polyoxyl 40 hydrogenated castor oil, trisodium nitrilotriacetate, water.

* Please review the disclaimer below.