NDC 73045-001 Cbd Unlimited Balmx Topical Analgesic

Menthol

NDC Product Code 73045-001

NDC Code: 73045-001

Proprietary Name: Cbd Unlimited Balmx Topical Analgesic 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.

NDC Code Structure

  • 73045 - Endexx Corporation
    • 73045-001 - Cbd Unlimited Balmx Topical Analgesic

NDC 73045-001-01

Package Description: 60 mL in 1 JAR

NDC Product Information

Cbd Unlimited Balmx Topical Analgesic with NDC 73045-001 is a a human over the counter drug product labeled by Endexx Corporation. The generic name of Cbd Unlimited Balmx Topical Analgesic is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Endexx Corporation

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 Unlimited Balmx Topical Analgesic 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 1.25 g/100mL

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.

  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • HEMP (UNII: TD1MUT01Q7)
  • CLOVE OIL (UNII: 578389D6D0)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)

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: Endexx Corporation
Labeler Code: 73045
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: 04-11-2019 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.

Cbd Unlimited Balmx Topical Analgesic Product Label Images

Cbd Unlimited Balmx Topical Analgesic 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 Ingredient

Menthol 1.25%

Purpose

Topical Analgesic

Inactive Ingredients

Arnica Oil, Beeswax,  Clove Bud Oil, Grapeseed Oil, Hemp Isolate, Hemp Seed Oil, Lavender Oil, MSM (Methylsulfonylmethane), MCT Coconut Oil, Organic Lemongrass Oil, Organic Moringa Oil, Sweet Birch Oil.

Uses

Temporary relief from minor aches and pains of muscles & joints associated with: arthritis, simple backache, strains, sprains

Warnings:

For external use only.Do not use on wounds or damaged skin.When using this product: Avoid contact with the eyes. Do not bandage tightly.Stop use and ask a doctor ifcondition worsens, or if  symptoms persist for more than 7 days or clear up and occur again within a few days.If pregnant or breast-feeding ask a health professional before use.

Keep Out Of Reach Of Children

If product is swallowed get medical help or contact a Poison Control Center right away.

Directions:

Adults and children 12 years of age & older. Rub well on affected area not more than 3 to 4 times daily. For children 12 years or younger, consult a doctor before use.

Distributed By:

CBD UNLIMITED INC

* Please review the disclaimer below.

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