NDC 0924-5750 First Aid Only Burn Mist

Lidocaine Hydrochloride

NDC Product Code 0924-5750

NDC 0924-5750-01

Package Description: 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

First Aid Only Burn Mist with NDC 0924-5750 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of First Aid Only Burn Mist is lidocaine hydrochloride. The product's dosage form is spray and is administered via topical form.

Labeler Name: Acme United Corporation

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.

First Aid Only Burn Mist 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.

  • LIDOCAINE HYDROCHLORIDE 2 g/100mL

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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • 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: 03-01-2018 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’.

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First Aid Only Burn Mist Product Label Images

First Aid Only Burn Mist 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 Ingredient

Lidocaine HCl 2%

Purpose

External analgesic

Uses

For the temporary relief of pain associated with minor burns

Warnings

For external use only

Do Not Use

In large quantities, particularly over raw surfaces or blistered areas

When Using This Product

Avoid contact with eyes

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 dayscondition clears up and occurs again within a few days

Keep Out Of The Reach Of Children

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

Dosage & Administration

  • Directionsadults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: consult a doctor

Other Information

  • Store at room temperature

Inactive Ingredients

Diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine

Questions

800.835.2263

* Please review the disclaimer below.