NDC 47682-450 Medi-first Protective Coating Bandage

Benzethonium Chloride And Benzocaine

NDC Product Code 47682-450

NDC CODE: 47682-450

Proprietary Name: Medi-first Protective Coating Bandage 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: Benzethonium Chloride And Benzocaine 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

  • 47682 - Unifirst First Aid Corporation
    • 47682-450 - Medi-first Protective Coating Bandage

NDC 47682-450-17

Package Description: 85 g in 1 BOTTLE, SPRAY

NDC Product Information

Medi-first Protective Coating Bandage with NDC 47682-450 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Medi-first Protective Coating Bandage is benzethonium chloride and benzocaine. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Unifirst First Aid 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.

Medi-first Protective Coating Bandage 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.

  • BENZETHONIUM CHLORIDE 170 mg/85g
  • BENZOCAINE 2720 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • ISOBUTANE (UNII: BXR49TP611)
  • BUTANE (UNII: 6LV4FOR43R)
  • PROPANE (UNII: T75W9911L6)
  • COPOVIDONE K25-31 (UNII: D9C330MD8B)

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: Unifirst First Aid Corporation
Labeler Code: 47682
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: 04-05-2013 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Medi-first Protective Coating Bandage Product Label Images

Medi-first Protective Coating Bandage 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 3.2% w/w

Purpose

Topical antisepticTopical anesthetic

Uses

First aid to help protect against infection inminor cuts and scrapesburns

Warnings

For external use onlyFlammablekeep 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 eyes or other mucus membranesin case of serious burnsin case of deep or puncture woundsfor a prolonged period of timeon a large portion of the body

Stop Use And Ask A Doctor If

Condition worsens or symptoms persist for more than 7 dayscondition clears up and recurs within a few daysredness, swelling, or irritation occurs

Directions

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

Other Information

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

Inactive Ingredients

Ethyl alcohol, isobutane, n-butane, propane, PVP-VA copolymer

* Please review the disclaimer below.