NDC 0924-5011 First Aid Only First Aid/burn

Lidocaine Hydrochloride And Benzalkonium Chloride

NDC Product Code 0924-5011

NDC 0924-5011-00

Package Description: .9 g in 1 PACKET

NDC 0924-5011-01

Package Description: 10 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC 0924-5011-02

Package Description: 12 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC 0924-5011-03

Package Description: 25 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC 0924-5011-04

Package Description: 144 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC Product Information

First Aid Only First Aid/burn with NDC 0924-5011 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of First Aid Only First Aid/burn is lidocaine hydrochloride and benzalkonium chloride. The product's dosage form is cream and is administered via topical form.

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.

First Aid Only First Aid/burn 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.

  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CETETH-20 (UNII: I835H2IHHX)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)
  • WATER (UNII: 059QF0KO0R)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
  • PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

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: 08-30-2021 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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First Aid Only First Aid/burn Product Label Images

First Aid Only First Aid/burn 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

Other

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%Lidocaine HCl 0.5%

Purpose

First Aid AntisepticExternal analgesic

Uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor: •cuts •scrapes •burns.

Warnings

For external use only.

Otc - Do Not Use

Do not use ▪in the eyes ▪over large areas of the body ▪in large quantities, particularly over raw surfaces or blistered areas ▪if you are allergic to any of the ingredients ▪on deep puncture wounds, animal bites, or serious burns

Otc - Stop Use

  • Stop use and ask a doctor if ▪condition worsens or clears up and occurs again within a few days ▪symptoms persist for more than 7 days ▪a rash or allergic reaction occurs

Keep Out Of Reach Of Children.

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

Directions

Adults - Clean the affected area, apply a small amount of product (equal to the surface area of a fingertip) 1 to 3 times daily.Children under 2- Consult a doctor

Other Information

Store in a cool dry area 150 – 250C (590 – 770F)

Inactive Ingredients

Butylated hydroxytoluene, ceteth-20, cetostearyl alcohol, dimethicone, glycerin, glyceryl monostearate, isopropyl myristate, methylcellulose, purified water, sodium EDTA, methyl paraben sodium, propylparaben sodium

Otc - Questions

Questions 1.800.835.2263

* Please review the disclaimer below.