NDC 79165-111 Elle Antibacterial Hand Wipes

Benzalkonium Chloride

NDC Product Code 79165-111

NDC 79165-111-20

Package Description: 20 PACKAGE in 1 PACKET > 3.6 g in 1 PACKAGE

NDC 79165-111-80

Package Description: 80 PACKAGE in 1 PACKET > 3.6 g in 1 PACKAGE

NDC 79165-111-90

Package Description: 90 PACKAGE in 1 PACKET > 3.6 g in 1 PACKAGE

NDC Product Information

Elle Antibacterial Hand Wipes with NDC 79165-111 is a a human over the counter drug product labeled by Alta Sales Inc. The generic name of Elle Antibacterial Hand Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Alta Sales Inc

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.

Elle Antibacterial Hand 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.

  • BENZALKONIUM CHLORIDE .13 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.

  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Alta Sales Inc
Labeler Code: 79165
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: 08-25-2020 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.

Elle Antibacterial Hand Wipes Product Label Images

Elle Antibacterial Hand 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

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Warnings

For external use onlyKeep out of eyes. In case of eye contact, rinse with water.If irritation develops, discontinue use.Consult a doctor if irritation persists more than 72 hours.If swallowed, seek medical attention or contact a Poison Control Center.

Otc - Keep Out Of Reach Of Children

Keep out of the children, except with adult supervision.

Directions For Use

Thoroughly wipe hands and face as desired.Allow to dry without wiping.Discard wipe in trash receptacle after use. Do not flush.

Inactive Ingredients

Aqua, Phenoxyethanol, Perfume, Propylene Glycol, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Benzoic acid, Tetrasodium Edta, Dehydroacetic acid, Glycerin, Polysorbate 20, Citric acid

* Please review the disclaimer below.