NDC 54622-303 Enmotion Antimicrobial Foam With Moisturizers
Benzalkonium Chloride Solution Topical

Product Information

Product Code54622-303
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.
Enmotion Antimicrobial Foam With Moisturizers
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 FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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.
Georgia-pacific Consumer Products
Labeler Code54622
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.
03-20-2017
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.
12-31-2022
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

Usage Information


Product Packages

NDC 54622-303-01

Package Description: 2 BAG in 1 BOX > 1200 mL in 1 BAG

Product Details

Enmotion Antimicrobial Foam With Moisturizers is a human over the counter drug product labeled by Georgia-pacific Consumer Products. The generic name of Enmotion Antimicrobial Foam With Moisturizers is benzalkonium chloride. The product's dosage form is solution and is administered via topical form.


What are Enmotion Antimicrobial Foam With Moisturizers Active Ingredients?

The following is the list of active ingredients in this product. 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.


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM PIDOLATE (UNII: 1V74VH163T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SORBITOL (UNII: 506T60A25R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • OAT (UNII: Z6J799EAJK)
  • ACAI (UNII: 46AM2VJ0AW)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)


* Please review the disclaimer below.

Enmotion Antimicrobial Foam With Moisturizers Labeling and Warnings

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.

Table of Contents



Other



Drug Facts


Active Ingredient



Benzalkonium chloride, 0.26% w/w


Purpose



Antiseptic


Use



Handwash to help reduce bacteria that potentially can cause disease.


Warnings



  • For external use only

When Using This Product



Avoid contact with eyes. In case of eye contact, flush with water.


Stop Use



if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.


Keep Out Of Reach Of Children.



If swallowed, seek immediate medical attention or call a poison control center.


Directions



Wet hands, apply soap, rub hands together vigorously for at least 20 seconds.

Rinse and dry hands thoroughly with a disposable paper towel.


Inactive Ingredients



Water (Aqua), Lauramine Oxide, Cocamidopropyl Betaine, Glycerin, Sodium PCA, Tocopheryl Acetate, Sorbitol, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Extract, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Euterpe Oleracea Fruit Extract, Propylene Glycol, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol, Tetrasodium EDTA, Citric Acid.


Package Label.Principal Display Panel



enMotion
Antimicrobial Foam Soap With Moisturizers
Fragrance Free, Dye Free, Triclosan-Free
Net Contents 2-1200mL (40.5 FL OZ)
Made in Mexico
enMotion is a trademark of Georgia-Pacific Consumer Products LP.
Contact Georgia-Pacific at 1-866-HELLOGP(1-866-435-5647)


* Please review the disclaimer below.