NDC 11084-306 Appeal Non-alcohol Foaming Hand Sanitizer
Benzalkonium Chloride Liquid Topical

Product Information

What is NDC 11084-306?

The NDC code 11084-306 is assigned by the FDA to the product Appeal Non-alcohol Foaming Hand Sanitizer which is a human over the counter drug product labeled by Sc Johnson Professional Usa, Inc.. The generic name of Appeal Non-alcohol Foaming Hand Sanitizer is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form. The product is distributed in a single package with assigned NDC code 11084-306-27 1000 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code11084-306
Proprietary Name 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.
Appeal Non-alcohol Foaming Hand Sanitizer
Non-Proprietary Name 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.
Benzalkonium Chloride
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Sc Johnson Professional Usa, Inc.
Labeler Code11084
FDA Application Number 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.
part333E
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
11-01-2020
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Appeal Non-alcohol Foaming Hand Sanitizer?


Product Packages

NDC Code 11084-306-27

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

Product Details

What are Appeal Non-alcohol Foaming Hand Sanitizer Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Appeal Non-alcohol Foaming Hand Sanitizer Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Appeal Non-alcohol Foaming Hand Sanitizer Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Appeal Non-alcohol Foaming Hand Sanitizer Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts

Distributed exclusively by:
Interline Brands
Jacksonville, FL 32207


Active Ingredient



Benzalkonium Chloride, 0.13%


Purpose



Antiseptic


Uses



  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings



For external use only


When Using This Product



  • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • Avoid contact with broken skin.
  • Do not inhale or ingest.

Stop Use And Ask A Doctor If



  • irritation and redness develop
  • condition persists for more than 72 hours

Otc - Keep Out Of Reach Of Children



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


Directions



  • Wet hands thouroughly with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.

Inactive Ingredients



Aqua, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Cocamidopropyl Betaine, Lauramine Oxide, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA


Principal Display Panel - 1 Liter Bottle Label



NDC 11084-306-27

APP17103-04
102669

appeal

Non-alcohol
Foaming Hand Sanitizer
(dye and fragrance free)

1 Liter (33.8 fl oz)

Distributed exclusively by:
Interline Brands
Jacksonville, FL 32207
www.AppealProducts.com

Made by
SCJ PROFESSIONAL
A Family Company™

1000003257/1020


* Please review the disclaimer below.