NDC 79374-140 Rawharvest Hand Sanitizer Sensitive Skin

Benzalkonium Chloride

NDC Product Code 79374-140

NDC 79374-140-01

Package Description: 20 mL in 1 BOTTLE, SPRAY

NDC 79374-140-02

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC 79374-140-03

Package Description: 60 mL in 1 BOTTLE, SPRAY

NDC 79374-140-04

Package Description: 90 mL in 1 BOTTLE, SPRAY

NDC 79374-140-05

Package Description: 120 mL in 1 BOTTLE, SPRAY

NDC 79374-140-06

Package Description: 240 mL in 1 BOTTLE, SPRAY

NDC 79374-140-07

Package Description: 480 mL in 1 BOTTLE, SPRAY

NDC 79374-140-08

Package Description: 750 mL in 1 BOTTLE, SPRAY

NDC 79374-140-09

Package Description: 950 mL in 1 BOTTLE, SPRAY

NDC 79374-140-10

Package Description: 1893 mL in 1 JUG

NDC 79374-140-11

Package Description: 3785 mL in 1 JUG

NDC 79374-140-12

Package Description: 208000 mL in 1 DRUM

NDC 79374-140-13

Package Description: 1045000 mL in 1 CONTAINER

NDC Product Information

Rawharvest Hand Sanitizer Sensitive Skin with NDC 79374-140 is a a human over the counter drug product labeled by American Organic Food Company Llc. The generic name of Rawharvest Hand Sanitizer Sensitive Skin is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: American Organic Food Company Llc

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.

Rawharvest Hand Sanitizer Sensitive Skin 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/100mL

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.

  • UREA (UNII: 8W8T17847W)
  • 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: American Organic Food Company Llc
Labeler Code: 79374
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: 07-02-2020 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.

Rawharvest Hand Sanitizer Sensitive Skin Product Label Images

Rawharvest Hand Sanitizer Sensitive Skin 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 0.11% - 0.13%

Purpose

Antiseptic

Use

For hand sanitizing. Helps prevent the risk and spread of infection as well as communicable diseases by killing germs that reside on the surface of the skin.

Warnings

Do not use in eyes. In case of eye contact, immediately flush with water and seek medical advice.Discontinue use if skin irritation or redness develops.No for use on sensitive areas of the body or burns.

Otc - Keep Out Of Reach Of Children

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

Directions

Dispense 1 to 4 pumps into your palm. Rub foam until spread evenly over the entire surface of your hands.Continue rubbing until dry. Use frequently to avoid spreading germs.

Inactive Ingredients

Water 99.83%, Carbamide to 0.04%

* Please review the disclaimer below.