NDC 73279-0001 Lidocaine 4% Plus Menthol 1%

Lidocaine, Menthol

NDC Product Code 73279-0001

NDC 73279-0001-2

Package Description: 5 PATCH in 1 POUCH > 6 g in 1 PATCH (73279-0001-1)

NDC Product Information

Lidocaine 4% Plus Menthol 1% with NDC 73279-0001 is a a human over the counter drug product labeled by Icure Pharmaceutical Inc, Wanju Factory. The generic name of Lidocaine 4% Plus Menthol 1% is lidocaine, menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Icure Pharmaceutical Inc, Wanju Factory

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.

Lidocaine 4% Plus Menthol 1% 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.

  • MENTHOL 1 g/100g
  • LIDOCAINE 4 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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Icure Pharmaceutical Inc, Wanju Factory
Labeler Code: 73279
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: 08-31-2019 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.

Lidocaine 4% Plus Menthol 1% Product Label Images

Lidocaine 4% Plus Menthol 1% 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

Otc - Active Ingredient

Lidocaine, menthol

Inactive Ingredient

Methylparaben, Propylparaben, Sodium Polyacrylate, Polyacrylic Acid 20% Solution, Gelatin, Carboxymethyl Cellulose, Titanium Oxide, Kaolin, Dihydroxyaluminium Aminoacetate, Concentrated Glycerin, D-Sorbitol Solution, Urea, Polysorbate 80, Sorbitan Oleate, Disodium Edetate Hydrate, Tartaric Acid, Propylene Glycol, Purified Water

Otc - Purpose

Temporary relief of minor pain

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Use only as directed. Read and follow all directions and warnings on this label.

Do not allow contact with the eyes and mucous membranes

Do not bandage tightly or apply local heat (such as heating pads) to the area of use

Do not use at the same time as other topical analgesics

Dispose of used patch in manner that always keeps product away from children and pets

Used patch still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests patch

Warnings

- Warnings

For external use only.

Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients.
- Do not Use

More than 1 patch on your body at a time or on cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

Dosage & Administration

For external use only

* Please review the disclaimer below.