NDC 71811-002 Hot And Cold Lidocaine With Menthol Patch Pain Relief

Lidocaine And Menthol

NDC Product Code 71811-002

NDC CODE: 71811-002

Proprietary Name: Hot And Cold Lidocaine With Menthol Patch Pain Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Lidocaine And Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to relieve nerve pain after shingles (infection with the herpes zoster virus). This type of pain is called post-herpetic neuralgia. Lidocaine helps to reduce sharp/burning/aching pain as well as discomfort caused by skin areas that are overly sensitive to touch. Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

NDC Code Structure

  • 71811 - Intermed
    • 71811-002 - Hot And Cold Lidocaine With Menthol Patch

NDC 71811-002-05

Package Description: 500 PATCH in 1 CASE > 1 PATCH in 1 PATCH

NDC Product Information

Hot And Cold Lidocaine With Menthol Patch Pain Relief with NDC 71811-002 is a a human over the counter drug product labeled by Intermed. The generic name of Hot And Cold Lidocaine With Menthol Patch Pain Relief is lidocaine and menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Intermed

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.

Hot And Cold Lidocaine With Menthol Patch Pain Relief 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 240 mg/1
  • MENTHOL 60 mg/1

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.

  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.
  • 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: Intermed
Labeler Code: 71811
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: 11-22-2019 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.

Hot And Cold Lidocaine With Menthol Patch Pain Relief Product Label Images

Hot And Cold Lidocaine With Menthol Patch Pain Relief 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

Otc - Purpose

Active IngredientsPurposeLidocaine 4 % (240 mg)Topical analgesicMenthol 1%     (60 mg)Topical analgesic

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Warnings

For external use only.

Otc - Do Not Use

Do not use if you are allergic or sensitive to lidocaine or menthol. Do not use if pouch is damaged or opened.

When Using This Product

  • Use only as directed
  • Avoid contact with eyes or mucous membranes
  • Do not apply to open wounds or sensitive skin
  • Do not bandage tightly or use a heating pad

Stop Use And Ask A Doctor If

  • Excessive redness or irritation is present
  • Condition worsens
  • Pain persists for more than 7 days
  • Symptoms clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If











pregnant or breast-feeding, ask a health professional before use.

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: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
  • Children: consult your physician
  • Remove protective film, gently apply to affected area.

Inactive Ingredients

Dihydroxyaluminium aminoacetate, disodium EDTA, glycerin, methylparaben, polyvinyl alcohol, propyl


paraben, propylene glycol, purified water, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric


acid, titanium dioxide

* Please review the disclaimer below.