NDC 0924-5000 Lidocaine Hydrochloride

Lidocaine Hydrochloride

NDC Product Code 0924-5000

NDC 0924-5000-01

Package Description: 6 PACKET in 1 BOX > 3.5 g in 1 PACKET (0924-5000-00)

NDC 0924-5000-02

Package Description: 25 PACKET in 1 BOX > 3.5 g in 1 PACKET (0924-5000-00)

NDC Product Information

Lidocaine Hydrochloride with NDC 0924-5000 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Lidocaine Hydrochloride is lidocaine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Acme United Corporation

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Lidocaine Hydrochloride 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 20 mg/g

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • WATER (UNII: 059QF0KO0R)
  • MENTHOL (UNII: L7T10EIP3A)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: 02-14-2013 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: 12-31-2019 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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Information for Patients

Lidocaine Viscous

Lidocaine Viscous is pronounced as (lye' doe kane)

Why is lidocaine viscous medication prescribed?
Lidocaine viscous, a local anesthetic, is used to treat the pain of a sore or irritated mouth and throat often associated with cancer chemotherapy and certain medical pro...
[Read More]

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Lidocaine Hydrochloride Product Label Images

Lidocaine Hydrochloride 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

Lidocaine HCl 2%

Purpose

Topical pain relief

Uses

Temporary pain relief of minor burns. For professional use only.

For External Use Only. Keep Out Of Reach Of Children.

If ingested, get medical help or contact a Poison Control Center directly

Do Not Use

  • In large quantities, particularly over raw or blistered areas
  • Near eyes, if this happens rinse thoroughly with water

Stop Use And Ask Doctor If

  • The condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
Children under 2 years: do not use, consult a doctor

Other Information

  • Store at room temperature (do not freeze)
  • Do not use any opened or torn packs

Inactive Ingredients

Aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, Vitamin E acetate

* Please review the disclaimer below.