NDC 73423-004 Cbd Heat Relief

Methyl Salicylate

NDC Product Code 73423-004

NDC 73423-004-01

Package Description: 6 BOTTLE, SPRAY in 1 PACKAGE > 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Cbd Heat Relief with NDC 73423-004 is a a human over the counter drug product labeled by Global Widget, Llc. The generic name of Cbd Heat Relief is methyl salicylate. The product's dosage form is spray and is administered via topical form.

Labeler Name: Global Widget, Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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 Heat 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.

  • METHYL SALICYLATE 60 mg/mL

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.

  • ETHYL SALICYLATE (UNII: 555U6TZ2MV)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • WHITE PINE OIL (UNII: HA5CX6676U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
  • VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CANNABIDIOL (UNII: 19GBJ60SN5)

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.

Listing Expiration Date: 12-31-2021 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 Heat Relief Product Label Images

Cbd Heat 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

Active Ingredients

Methyl Salicylate  6%

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 Methyl Salicylate, Aspirin, Ibuprofen, any other inflammatory  ingredient or 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 inhaleDo not consume this product

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

  • Shake well before use Adults 18 years & over apply to affected areasHow to apply: Spray 3 or 4 times per day as needed on the affected area and wash hands  immediately after use

Other Information:

Store in cool, dry place away from direct sunlight. Store at 68° - 77°F (20° - 25°C).Keep away from flame

Inactive Ingredients

Ethyl Salicylate, Isopropyl Alcohol, Ricinoleic Acid (Castor Oil), Pine Oil, Glycerin, Peppermint Oil, Spiraea Ulmaria Extract (Meadowsweet), Vanillyl Butyl Ether, Polysorbate 80, Pure CBD Extract

Distributed By

Global Widget, LLC8419 Sunstate Street, Tampa, FL 33634

* Please review the disclaimer below.