NDC 75009-103 Foam 103

Antibacterial Foaming Soap

NDC Product Code 75009-103

NDC 75009-103-01

Package Description: 3787 g in 1 JUG

NDC 75009-103-02

Package Description: 18933 g in 1 PAIL

NDC 75009-103-03

Package Description: 208269 g in 1 DRUM

NDC 75009-103-04

Package Description: 1041556 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

NDC Product Information

Foam 103 with NDC 75009-103 is a a human over the counter drug product labeled by Alpha Aromatics. The generic name of Foam 103 is antibacterial foaming soap. The product's dosage form is soap and is administered via topical form.

Labeler Name: Alpha Aromatics

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.

Foam 103 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 .15 g/100g

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.

  • DIHYDROMYRCENOL (UNII: 46L1B02ND9)
  • HEXYL ACETATE (UNII: 7U7KU3MWT0)
  • WATER (UNII: 059QF0KO0R)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Alpha Aromatics
Labeler Code: 75009
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: 05-25-2020 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.

Foam 103 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 0.15%(w/w)

Purpose

Anitbacterial

Use

Handwash to help decrease bacteria on the skin

Warnings

For external use only. Avoid contact with eyes. If eye contact occurs, flush eyes with water.Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.

Otc - Stop Use

Stop use if, in rare instances, redness or irrtiation develops. If condition persists for more than 72 hours, consult a physician.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, contact a physician or poison control center.

Directions

To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, and rinse.

Inactive Ingredients

Water, sorbitol, glycerine, decyl glucoside, dmdm hydantoin, fragrance.

* Please review the disclaimer below.