NDC 79605-022 Ecosoft Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 79605-022

NDC 79605-022-02

Package Description: 60 mL in 1 BOTTLE, PLASTIC

NDC 79605-022-08

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC 79605-022-16

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC 79605-022-32

Package Description: 947 mL in 1 BOTTLE, PLASTIC

NDC 79605-022-50

Package Description: 3780 mL in 1 BOTTLE, PLASTIC

NDC 79605-022-55

Package Description: 208000 mL in 1 DRUM

NDC 79605-022-75

Package Description: 1041000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

NDC Product Information

Ecosoft Hand Sanitizer with NDC 79605-022 is a a human over the counter drug product labeled by Organic Beauty Unlimited Llc. The generic name of Ecosoft Hand Sanitizer is benzalkonium chloride. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Organic Beauty Unlimited Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Ecosoft Hand Sanitizer 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.

  • WATER (UNII: 059QF0KO0R)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • JOJOBA OIL (UNII: 724GKU717M)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • GRAPEFRUIT (UNII: O82C39RR8C)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • POMEGRANATE (UNII: 56687D1Z4D)
  • RASPBERRY (UNII: 4N14V5R27W)

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: Organic Beauty Unlimited Llc
Labeler Code: 79605
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: 07-13-2020 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.

Ecosoft Hand Sanitizer 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

Antiseptic

Inactive Ingredients

Deionized water, glycerin, sunflower oil, shea butter, avocado oil, aloe vera gel, lecithin, jojoba oil, almond oil, grape seed oil, pomegranate, raspberry, grapefruit, eucalyptus oil, hydroxyethyl cellulose

Directions

Apply enough product in palm of hand to cover hands completely. Gently rub and massage into hands until dry. Children under 6 years of age should have adult supervision when using this product.

Warnings

For external use only. Do not use in the eyes. In case of eye contact flush eyes with water.Stop use and ask a doctor if irritation and redness develop

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Uses

Hand sanitizer to help reduce bacteria on the skin. Repeated use recommended

Other Information

Store under 105°F

* Please review the disclaimer below.