NDC 79740-007 Hemp Powered

Menthol 10.5%

NDC Product Code 79740-007

NDC 79740-007-02

Package Description: 1 CAN in 1 CARTON > 90 mL in 1 CAN

NDC Product Information

Hemp Powered with NDC 79740-007 is a a human over the counter drug product labeled by The Anthos Group. The generic name of Hemp Powered is menthol 10.5%. The product's dosage form is spray and is administered via topical form.

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.

Hemp Powered 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
  • TURMERIC (UNII: 856YO1Z64F)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • JUNIPER BERRY (UNII: O84B5194RL)
  • WATER (UNII: 059QF0KO0R)
  • APOCYNUM CANNABINUM ROOT (UNII: 2F92409L9Z)

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: The Anthos Group
Labeler Code: 79740
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: 06-23-2021 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 - 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".

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Hemp Powered Product Label Images

Hemp Powered 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                       Purpose

Menthol                                        10.5%

Uses:

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

Warnings For External Use Only

Flammable: Do not use while smocking or near heat of flame.


When using this product• Avoid contact with eyes or mucous membranes


• Do not apply to wounds or damage skin


• Do not apply to the irritated skin


• Do not bandage skin


• Wash hands after use with cool water


• Do not use with heating pad or device


• Avoid spraying in eyes. Content under pressure. Do not puncture or incinerat.


• Do not store at temperature above 120°


Stop use and ask doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

Direction

• Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily


• Children under 2 years old: consult a doctor

Inactive Ingredients

Alcohol Denat.


Arnica Montana Flower Extract


Calendula Officinalis Flower Extract


Camellia Sinensis Leaf Extract


Chamomile Recutita Flower Extract


Curcuma Longa (Turmeric) Root Extract


Dimethyl Sulfone


Echinacea Angustifolia Extract


Ilex Paraguariensis Leaf Extract


Isopropyl Myristate


Juniperus Communis Fruit Extract


Water


Whole Hemp Extract (Isolate)

Questions?

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* Please review the disclaimer below.