NDC 73423-009 Cbd Pain

Lidocaine

NDC Product Code 73423-009

NDC CODE: 73423-009

Proprietary Name: Cbd Pain 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 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

  • 73423 - Global Widget, Llc

NDC 73423-009-01

Package Description: 2 PATCH in 1 POUCH > 1 PATCH in 1 PATCH

NDC Product Information

Cbd Pain with NDC 73423-009 is a a human over the counter drug product labeled by Global Widget, Llc. The generic name of Cbd Pain is lidocaine. The product's dosage form is patch and is administered via topical form.

Labeler Name: Global Widget, Llc

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.

Cbd Pain 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 23 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.

  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • CROSPOVIDONE (UNII: 2S7830E561)
  • POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)

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: Global Widget, Llc
Labeler Code: 73423
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: 01-04-2021 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.

Cbd Pain Product Label Images

Cbd Pain 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%

Purpose

Topical Analgesic

Uses

For the temporary relief of  pain

Warnings

FOR EXTERNAL USE ONLY

Do Not Use If Pouch Is Damaged Or Open.Do Not Use:

  • On eyes or on mucous membranesOn wounds, damaged or irritated skinIf you are allergic to Lidocaine or any of the ingredients listed below

When Using This Product:

  • Use only as directedDo not bandage or cover with any type of wrap except clothingDo not use with heating pad or devices, or apply external heatDo not use 1 hour prior to bathing or 30 minutes after bathing

Stop Use And Ask A Doctor If

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blisteringConditions worsenSymptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding: Do not use this product.

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 18 years & over apply to affected areaHow to apply:
  • • Use scissors to cut open the pouch
  • • Remove clear protective liner from patch
  • • Wash hands after applying patch
  • • Be sure patch is dry and slowly remove from skin
  • • Only use one patch at a time and leave the patch on for no more than 12 hours
  • • Rotate the location of the patch, do not place in the same location two days in a row

Other Information:

Reseal package after removing one patch. Store in cool, dry place away from direct sunlight. Store 68° - 77°F (20°- 25°C). Do not allow to freeze.

Inactive Ingredients

Pure CBD Extract, Crossprovidone, Non-woven Backing Fabric, Polyester Film, Polyisobutylene

Distributed By

Global Widget, LLC8419 Sunstate Street, Tampa, FL 33634

* Please review the disclaimer below.