NDC 81238-0315 Soothe-a-sting

Alcohol, Benzocaine

NDC Product Code 81238-0315

NDC 81238-0315-1

Package Description: 3 mL in 1 PACKET

NDC Product Information

Soothe-a-sting with NDC 81238-0315 is a a human over the counter drug product labeled by Western First Aid Safety Dba Aramark. The generic name of Soothe-a-sting is alcohol, benzocaine. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Western First Aid Safety Dba Aramark

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Soothe-a-sting 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.

  • ALCOHOL .5 mL/mL
  • BENZOCAINE .02 g/mL

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.

  • WATER (UNII: 059QF0KO0R)

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: 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: 04-09-2021 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".

* Please review the disclaimer below.

Soothe-a-sting Product Label Images

Soothe-a-sting 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

Drug FactsActive IngredientsEthyl alcohol 50.0%Benzocaine 2.0%

Otc - Purpose

PurposeEthyl alcohol .......... AntisepticBenzocaine ........... Topical pain relief

Indications & Usage

Uses   temporary relief of pain and itching caused by insect bites and stings.

Warnings

WarningsFor external use only. Flammable. Keep away from fire or flame.

Otc - Do Not Use

Do not use ■ in large quantities, particularly overraw or blistered areas ■ near eyes, if this happenswinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, getmedical help or contact a Poison Control Centerright away.

Dosage & Administration

Directions ■spread an even layer of Sing Reliefover affected area not mor than 3 to 4 times daily■ for children under 2 years of age consult a physician

Inactive Ingredient

Inactive ingredients purified water

Product Label

Aramark : The First Choice In First AidSOOTHE-A-STING™ WIPENDC # 81238-0315-11 premoistened toweletteManufactured for Aramarkaramark        Lenexa, KS 66219                     913-269-9611LOTres

* Please review the disclaimer below.