NDC 81238-1030 Aramark Medi-band

Benzethonium Chloride, Benzocaine

NDC Product Code 81238-1030

NDC 81238-1030-1

Package Description: 85 g in 1 BOTTLE, SPRAY

NDC Product Information

Aramark Medi-band with NDC 81238-1030 is a a human over the counter drug product labeled by Western First Aid Safety Dba Aramark. The generic name of Aramark Medi-band is benzethonium chloride, benzocaine. The product's dosage form is spray and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1049110.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Aramark Medi-band 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.


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

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: Western First Aid Safety Dba Aramark
Labeler Code: 81238
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: 06-16-2021 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: 12-31-2022 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".

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Aramark Medi-band Product Label Images

Aramark Medi-band 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

Otc - Active Ingredient

Active IngredientsBenzethonium Chloride 0.2% w/wBenzocaine 3.2% w/w

Otc - Purpose

PurposeBenzethonium Chloride .........Topical AntisepticBenzocaine 3.2% ................Topical Anesthetic

Indications & Usage

UsesFirst Aid to help protect against infection in • minor cuts• scrapes • burns

Warnings

WarningsFor external use onlyFlammable • keep away from fire or flame • contents under pressure• do not puncture or incinerate container• do not expose to temperatures above 120°(F)

Otc - Do Not Use

Do not use • in or near the eyes or other mucous membranes• in case of serious burn • in deep puncture wounds• for prolonged period of time • on large portions of the body

Otc - Stop Use

Stop use and ask a doctor • if redness, swelling, or irritation occurs• infection occurs • condition persists or worsens• symptoms persist for more than 7 days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children  • If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions • clean the affected area • shake can well before using• hold can 4 to 6 inches away from injury and spray area until wet• for adult institutional use only • not intended for use on children

Other Safety Information

Other information • avoid inhaling • use only as directed• intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal

Inactive Ingredient

Inactive Ingredients Ethyl Alcohol, PVP-VA Copolymer, N-Butane, Propane, Isobutane

Principal Display

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