NDC 73423-003 Cbd Pain Freeze Shrink

Menthol Gel Topical

  1. Labeler Index
  2. Global Widget, Llc
  3. NDC: 73423-003 Cbd Pain Freeze Shrink

NDC Product Code 73423-003

NDC CODE: 73423-003

Proprietary Name: Cbd Pain Freeze Shrink 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: 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 product is used as topical analgesic

NDC Code Structure

NDC 73423-003-01

Package Description: 12 BOTTLE in 1 PACKAGE > 28 g in 1 BOTTLE

NDC Product Information

Cbd Pain Freeze Shrink with NDC 73423-003 is a human over the counter drug product labeled by Global Widget, Llc. The generic name of Cbd Pain Freeze Shrink is menthol. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Freeze Shrink 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)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: 12-15-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
End Marketing Date: 01-31-2024 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.

Cbd Pain Freeze Shrink Product Label Images

Cbd Pain Freeze Shrink 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

Menthol USP  4%

Purpose

Topical Analgesic

Uses

For the temporary relief of  pain

Warnings

FOR EXTERNAL USE ONLY

Do Not Use:

  • On eyes or on mucous membranesOn wounds, damaged or irritated skinIf you are allergic to Menthol 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 heat

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 rub a thin layer into affected areas up to 4 times daily.


•


Wash hands after application.

Other Information:

Store in cool, dry place away from direct sunlightDo not use if seal is broken or not present

Inactive Ingredients

Water, Isopropyl Alcohol, Carbomer, Pure CBD Extract, Triethanolamine

Distributed By

Global Widget, LLC8419 Sunstate Street, Tampa, FL 33634

* Please review the disclaimer below.