NDC 44224-0012 Easy Care First Aid Afterburn

Benzalkonium Chloride, Lidocaine

NDC Product Code 44224-0012

NDC 44224-0012-1

Package Description: .9 g in 1 PACKET

NDC 44224-0012-2

Package Description: 6 PACKET in 1 BOX > .9 g in 1 PACKET

NDC 44224-0012-3

Package Description: 100 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC Product Information

Easy Care First Aid Afterburn with NDC 44224-0012 is a a human over the counter drug product labeled by Tender Corporation. The generic name of Easy Care First Aid Afterburn is benzalkonium chloride, lidocaine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Tender Corporation

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Easy Care First Aid Afterburn 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.

  • BENZALKONIUM CHLORIDE .13 g/100g
  • LIDOCAINE HYDROCHLORIDE .5 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.

  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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: Tender Corporation
Labeler Code: 44224
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: 09-01-2019 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.

Easy Care First Aid Afterburn Product Label Images

Easy Care First Aid Afterburn 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

Benzalkonium Chloride 0.13%

Lidocaine HCL 0.5%

Purpose

First Aid AntisepticTopical Analgesic

Uses

  • Temporary relief of pain associated with minor burnshelps protect against harmful bacteria

Warnings

For external use only.

Do Not Use

  • In the eyesin large quantitieson animal bites, serious burns, deep puncture wounds, raw surfaces, or blistered areasfor more than one week unless directed to do so by a doctor

Stop Use And Ask A Doctor If

  • Condition worsensif symptoms persist for more than 7 days or clears up and occurs again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 years of age and older: clean the affected area; apply a small amount to the area 1-3 times daily; may be covered with a sterile bandage (let dry first).children under 2 years of age: consult a doctor

Inactive Ingredients

Glycerin monostearate, glycerol, purified water, sodium dodecyl sulfate

* Please review the disclaimer below.