NDC 73045-003 Cbd Unlimited Balm Topical Analgesic

Menthol

NDC Product Code 73045-003

NDC 73045-003-01

Package Description: 60 mL in 1 JAR

NDC Product Information

Cbd Unlimited Balm Topical Analgesic with NDC 73045-003 is a a human over the counter drug product labeled by Endexx Corporation. The generic name of Cbd Unlimited Balm 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 Balm 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 125 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.

  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68)
  • MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CLOVE OIL (UNII: 578389D6D0)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)

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.
  • 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: 05-05-2020 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 Unlimited Balm Topical Analgesic Product Label Images

Cbd Unlimited Balm 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

Uses

For the temporary relief of minor aches andpains of muscles and joints associated with arthritis, backache, strains and sprains.

Warnings:

Warnings: For external use only.When using this product:• use only as directed • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged, broken or irritated skin • do not spray onto face • avoid inhaling spray mist and fumesStop use and ask doctor if• condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clears up and occurs again within a few daysFlammable• do not use near heat or open _ame or while smokingIf pregnant or breast-feeding, ask a healthcareprofessional before use.Keep out of the reach of children

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions:

Adults and children 12 years of age and older: Apply on affected areas 1 to 4 times daily. Avoid contact with eyes & mouth.

Inactive Ingredients

Arnica Extract (Glycerin, Water, Arnica Montana Flower Extract), Beeswax, Clove Bud Oil, Grapeseed Oil, Hemp-Derived Cannabadiol Isolate, Hemp Seed Oil, Lavender Oil, Methylsulfonylmethane (MSM), MCT Coconut Oil, Lemongrass Oil, Moringa Oil, Sweet Birch Oil

* Please review the disclaimer below.