NDC 47682-450 Medi-first Protective Coating Bandage
Benzethonium Chloride And Benzocaine Aerosol, Spray Topical

Product Information

Medi-first Protective Coating Bandage is 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.

Product Code47682-450
Proprietary Name 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.
Medi-first Protective Coating Bandage
Non-Proprietary Name 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.
Benzethonium Chloride And Benzocaine
Product Type 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.
Human Otc Drug
Dosage FormAerosol, 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.
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.
Unifirst First Aid Corporation
Labeler Code47682
FDA Application Number 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.
part333A
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-05-2013
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Medi-first Protective Coating Bandage?


Product Packages

NDC 47682-450-17

Package Description: 85 g in 1 BOTTLE, SPRAY

Product Details

What are Medi-first Protective Coating Bandage Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • BENZETHONIUM CHLORIDE 170 mg/85g - Bactericidal cationic quaternary ammonium surfactant used as a topical anti-infective agent. It is an ingredient in medicaments, deodorants, mouthwashes, etc., and is used to disinfect apparatus, etc., in the food processing and pharmaceutical industries, in surgery, and also as a preservative. The compound is toxic orally as a result of neuromuscular blockade.
  • BENZOCAINE 2720 mg/85g - A surface anesthetic that acts by preventing transmission of impulses along NERVE FIBERS and at NERVE ENDINGS.

Medi-first Protective Coating Bandage Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1049110 - benzethonium Cl 0.2 % / benzocaine 3.2 % Topical Spray
  • RxCUI: 1049110 - benzethonium chloride 2 MG/ML / benzocaine 32 MG/ML Topical Spray

Medi-first Protective Coating Bandage Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Medi-first Protective Coating Bandage Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients



Benzethonium Chloride 0.2% w/w
Benzocaine 3.2% w/w 


Purpose



Topical antiseptic
Topical anesthetic 


Uses



First aid to help protect against infection in

minor cuts and scrapes
burns 


Warnings



For external use only

Flammable
keep away from fire or flame
contents under pressure
do not puncture or incinerate container
do not expose to temperatures above 120° F 


Do Not Use



in or near eyes or other mucus membranes
in case of serious burns
in case of deep or puncture wounds
for a prolonged period of time
on a large portion of the body 


Stop Use And Ask A Doctor If



condition worsens or symptoms persist for more than 7 days
condition clears up and recurs within a few days
redness, swelling, or irritation occurs 


Directions



clean the affected area
shake can well before using
hold 4-6 inches from surface and spray area until wet
may be covered with sterile bandage. If bandaged, let dry first
for adult institutional use only
not intended for use on children 


Other Information



avoid inhaling
use only as directed
intentional 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.