NDC 44224-3120 Benzocaine And Benzethonium

Benzocaine And Benzethonium

NDC Product Code 44224-3120

NDC 44224-3120-1

Package Description: 85 g in 1 CAN

NDC Product Information

Benzocaine And Benzethonium with NDC 44224-3120 is a a human over the counter drug product labeled by Tender Corporation. The generic name of Benzocaine And Benzethonium is benzocaine and benzethonium. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Tender Corporation

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous 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.

Benzocaine And Benzethonium 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.

  • BENZOCAINE 8500 mg/85g

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.

  • PROPANE (UNII: T75W9911L6)

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: Tender Corporation
Labeler Code: 44224
FDA Application Number: part348 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: 08-19-2014 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’.

* Please review the disclaimer below.

Benzocaine And Benzethonium Product Label Images

Benzocaine And Benzethonium 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 Ingredients

Benzethonium Chloride 0.2% w/wBenzocaine 10% w/w


Topical AntisepticTopical Anesthetic


  • For temporary relief of pain, treatment and helps prevent infection inminor cuts and scrapesinsect bitesminor skin irritations


For external use only


  • Keep away from fire or flamecontents under pressuredo not puncture or incinerate containerdo not expose to temperatures above 120°F

Do Not Use:

  • In or near mucous membraneson serious burnson deep puncture woundsfor a prolonged period of timeon a large portion of the body

Stop Use And Ask A Doctor If:

  • Redness, swelling, or irritation occursinfection occurscondition persists or worsenssymptoms persists for more than 7 days

Keep Out Of Reach Of Children.

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


  • Clean the affected areashake can well before usingfor adult institutional use onlynot for use on childrenhold 4-6 inches from surface and spray area until wetmay be covered with sterile bandage. If bandaged, let dry first

Other Information

  • Avoid inhalinguse only as directedintentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal

Inactive Ingredients

Dipropylene Glycol, Isobutane, n-Butane, Propane

* Please review the disclaimer below.