NDC 54622-303 Enmotion Antimicrobial Foam With Moisturizers

Benzalkonium Chloride

NDC Product Code 54622-303

NDC CODE: 54622-303

Proprietary Name: Enmotion Antimicrobial Foam With Moisturizers 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.

Non-Proprietary Name: Benzalkonium Chloride 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.

NDC Code Structure

  • 54622 - Georgia-pacific Consumer Products
    • 54622-303 - Enmotion Antimicrobial Foam With Moisturizers

NDC 54622-303-01

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

NDC Product Information

Enmotion Antimicrobial Foam With Moisturizers with NDC 54622-303 is a 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.

Labeler Name: Georgia-pacific Consumer Products

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Enmotion Antimicrobial Foam With Moisturizers 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 .26 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.

  • 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)

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.

Labeler Name: Georgia-pacific Consumer Products
Labeler Code: 54622
FDA Application Number: part333E 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: 03-20-2017 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.

Enmotion Antimicrobial Foam With Moisturizers Product Label Images

Enmotion Antimicrobial Foam With Moisturizers 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

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.

* Please review the disclaimer below.