NDC 64009-200 Foamyiq E2 Sanitizing Handwash

Benzalkonium Chloride

NDC Product Code 64009-200

NDC 64009-200-06

Package Description: 1.25 L in 1 CONTAINER

NDC Product Information

Foamyiq E2 Sanitizing Handwash with NDC 64009-200 is a a human over the counter drug product labeled by Spartan Chemical Company. The generic name of Foamyiq E2 Sanitizing Handwash is benzalkonium chloride. The product's dosage form is soap and is administered via topical form.

Labeler Name: Spartan Chemical Company

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Foamyiq E2 Sanitizing Handwash 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 g/L

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)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
  • COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Spartan Chemical Company
Labeler Code: 64009
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: 12-03-2019 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: 12-31-2020 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’.

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Foamyiq E2 Sanitizing Handwash Product Label Images

Foamyiq E2 Sanitizing Handwash 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 Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

  • For hand washing to decrease bacteria on the skin.
  • Recommended tor repeated use.

Warnings

  • For external use only

Otc - When Using

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Otc - Stop Use

Stop use and ask a doctor if irritation and redness develops, or if condition persists for more than 72 hours.

Keep Out Of Reach Of Children.

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

Directions

  • Pump a small amount of foam into palm of hand.
  • Rub thoroughly over all surfaces of both hands for 15 seconds.
  • Rinse with potable water.

Other Information

  • This product must be dispensed from an adequate dispenser located a sufficient distance from processing line to prevent accidental product contamination.
  • Do not contaminate water, food or feed by storage and disposal.

Inactive Ingredients

Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid

Questions?

1-800-537-8990

* Please review the disclaimer below.