NDC 81484-301 Lidocaine Patchs

Lidocaine 4% Menthol 1%

NDC Product Code 81484-301

NDC 81484-301-02

Package Description: 6 BAG in 1 BOX > 1 PATCH in 1 BAG (81484-301-01)

NDC Product Information

Lidocaine Patchs with NDC 81484-301 is a a human over the counter drug product labeled by Anhui Miao De Tang Pharmaceutical Co., Ltd.. The generic name of Lidocaine Patchs is lidocaine 4% menthol 1%. The product's dosage form is patch and is administered via topical form.

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 Patchs 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • TARTARIC ACID (UNII: W4888I119H)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)

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: Anhui Miao De Tang Pharmaceutical Co., Ltd.
Labeler Code: 81484
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: 11-01-2021 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".

* Please review the disclaimer below.

Lidocaine Patchs Product Label Images

Lidocaine Patchs 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

LIDOCAINE PATCH

Active Ingredient(S)

LIDOCAINE 4% Purpose:Topical AnalgesicMENTHOL 1% Purpose: External Analges

Purpose

Topical Anesthetic, External Analges, LIDOCAINE PATCH

Use

LIDOCAINE PATCH to help Temporarily relteves minor pain

Warnings

For external use only. Flammable.

Do Not Use

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

• On open or puncture wounds
• For more than one week without consulling a doctor.

Otc - When Using

• Use only as directed. Read and邸ow all directions and warnings on this label.

• Rare cases of serious burns have been reported with products of this type.

• Oo not apply to wou心s or damaged, broken or irritated skin

• 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 producl away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:
• Wash and dry the affected area.

• Remove backing from patch by firmty grasping both ends and gently pulling until backing separates in the middle

• Carefully remove smaller portion of back,ng from patch and apply exposed portion of patch to a什ected area

• Once exposed portion of patch is po奾oned.carefully remove remaining backing tocomplelely apply patch to affected area.

• Carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area

• Use only 1 patch for a maximum of 24 hours.

Other Information

  • Store at room temperature - do not exceed 86'F, 30'C

Inactive Ingredients

Aluminum glycinate, glycerin, sodium polyacrylate. tartaric acid, DMOM hydantoin, water

* Please review the disclaimer below.