NDC 74884-301 Antibacterial

Benzalkonium Chloride

NDC Product Code 74884-301

NDC 74884-301-02

Package Description: 60 g in 1 TUBE

NDC Product Information

Antibacterial with NDC 74884-301 is a a human over the counter drug product labeled by As Beauty. The generic name of Antibacterial is benzalkonium chloride. The product's dosage form is lotion and is administered via topical form.

Labeler Name: As Beauty

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Antibacterial 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 .13 g/.13g

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.

  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
  • TREHALOSE (UNII: B8WCK70T7I)
  • GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
  • CHAMOMILE (UNII: FGL3685T2X)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

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: As Beauty
Labeler Code: 74884
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: 12-15-2020 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.

Antibacterial 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

Dosage & Administration

Pump product into hands and rub thoroughly until completely absorbed.

Inactive Ingredient

Water, Isononyl Isononanoate, Cetyl Ethylhexanoate, Propanediol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Cetearyl Glucoside, Sorbitan Olivate, Stearic Acid, Cetearyl Alcohol. Butyrospermum Parkii (Shea) Butter, Panthenol, Trehalose, Chamomilla Recutita (Matricaria) Flower Extract, Polysorbate 20, PEG-4, Hydroxypropyl Methylcellulose, Phenoxyethanol, Caprylyl Glycol, Fragrance (Parfum

Indications & Usage

If rash or irritation occurs, stop using. Consult a physician if the condition worsens.

Otc - Keep Out Of Reach Of Children

Keep Out Of Reach Of Children

Otc - Purpose

Antibacterial

Warnings

For external use only. Do not use on cuts or open wounds.

* Please review the disclaimer below.