NDC 71662-001 Re-lieved Lidocaine Patch

Lidocaine Patch 4%

NDC Product Code 71662-001

NDC CODE: 71662-001

Proprietary Name: Re-lieved Lidocaine Patch 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 Patch 4% 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

  • 71662 - Transfer Technology

NDC 71662-001-06

Package Description: 5 mg in 1 POUCH

NDC Product Information

Re-lieved Lidocaine Patch with NDC 71662-001 is a a human over the counter drug product labeled by Transfer Technology. The generic name of Re-lieved Lidocaine Patch is lidocaine patch 4%. The product's dosage form is patch and is administered via topical form.

Labeler Name: Transfer Technology

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.

Re-lieved Lidocaine Patch 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 mg/100mg
  • LIDOCAINE 4 mg/100mg

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.

  • ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Transfer Technology
Labeler Code: 71662
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: 02-01-2021 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 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.

Re-lieved Lidocaine Patch Product Label Images

Re-lieved Lidocaine Patch 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 Ingredients

Lidocaine 4%Menthol 1%

Purpose

Topical Analgesic

Use

For the temporary relief of pain.

Warnings

For external use only. The adhesoin properties of this patch may cause an extended period of redness. Please visit www.re-lieved.com for more information.

Do Not Use

If you are allergic to Lidocaine. On open wounds or on damaged, broken or irritated skin. Remove immidiately if you sense a burning sensation after application.

When Using This Product

  • Do not use other topical productsDo not allow contact with eyes or mucous membranesKeep away from excessive heat. Do not apply heating pad to area of useApply only to clean, dry and untreated skinUse only as directed. Read and follow all directions and warnings on this label

Ask Your Doctor Or Pharmacist Before Use If You Are

Using blood thinning medication, steroids, or non-steroidal anti-inflammatory druns (NSAIDs), or if you have sensitive skin.

Stop Use Or Ask A Doctor If

  • Condition worsensSymptoms persist for more than 7 days

If Pregnant Or Breast Feeding

Ask a physician before use.

Keep Out Of Reach Of Children

If put in mouth, get medical help or contact a poison control center right away. Dispose of used product away from children and pets.

Directions Adults/Children 12 Years Or Older

  • Clean and dry affected areaPeel patch off plastic liner and place on affected area for no more than 12 hoursWash hands after applying patch.Under age 12, consult a physician before useFor easier removal of the patc, apply rubbing alcohol or baby oil to adhesive edge while gently peeling

Other Information

  • Store at room termperatureDo not exceed 100
  • O Fahrenheit, 38
  • O Celsius

Inactive Ingredients

Acrylic adhesive, Polyethylene fabric

* Please review the disclaimer below.