NDC 0924-5201 First Aid Only Sting Relief Pad

Benzocaine

NDC Product Code 0924-5201

NDC 0924-5201-01

Package Description: 1 PATCH in 1 POUCH > .42 g in 1 PATCH

NDC Product Information

First Aid Only Sting Relief Pad with NDC 0924-5201 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of First Aid Only Sting Relief Pad is benzocaine. The product's dosage form is patch and is administered via topical form.

Labeler Name: Acme United Corporation

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

First Aid Only Sting Relief Pad 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 6 g/100g

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.

  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • 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: Acme United Corporation
Labeler Code: 0924
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: 07-31-2017 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.

First Aid Only Sting Relief Pad Product Label Images

First Aid Only Sting Relief Pad 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

Active Ingredients Benzocaine, 6%

Purpose

Topical Analgesic

Use

Use For temporary relief of pain and itching associated with minor burns, scapes and insect bites

Warnings

Warnings •for external use only •flammable, keep away from fire or flame

Do Not Use

Do Not Use •in the eyes •if contact occurs, flush eyes with water

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

Directions

Directions •apply to affected area not more than 3 to 4 times daily, for adults and children 2 years of age or older•Children under 2 years: consult physician

Other Information

Other Information Store at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients

Inactive Ingredients isopropyl alcohol, purified water

* Please review the disclaimer below.