NDC 72593-158 Cbd Menthol Pain Relief Fast Acting Pain Roller

Menthol, Unspecified Form

NDC Product Code 72593-158

NDC 72593-158-12

Package Description: 88 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Cbd Menthol Pain Relief Fast Acting Pain Roller with NDC 72593-158 is a a human over the counter drug product labeled by Global Products Group, Llc. The generic name of Cbd Menthol Pain Relief Fast Acting Pain Roller is menthol, unspecified form. The product's dosage form is gel and is administered via topical form.

Labeler Name: Global Products Group, Llc

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 Menthol Pain Relief Fast Acting Pain Roller 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, UNSPECIFIED FORM 85 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)
  • GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)

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: Global Products Group, Llc
Labeler Code: 72593
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: 10-05-2020 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 Menthol Pain Relief Fast Acting Pain Roller Product Label Images

Cbd Menthol Pain Relief Fast Acting Pain Roller 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

Other

Drug Facts

Distributed by FORE

Active Ingredient

Natural Menthol, USP (8.5%)

Purpose

Topical Analgesic

Uses

  • Temporarily relieves muscle and joint pain associated with arthritismuscle achesmuscle strainsjoint pain.

Warnings

For external use only: Flammable: Keep away from excessive heat or open flame

Otc - Ask Doctor

  • Ask a doctor before use if you have sensitive skin or if you are taking any blood thinners

Otc - When Using

  • When using this product: Do not use on wounds or irritated skinDo not bandage tightly or use with a heating padWash hands after use with cool water

Otc - Pregnancy Or Breast Feeding

  • If pregnant or breastfeeding: Ask a health professional before use

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If accidentally swallowed, contact a doctor or poison control center immediately

Otc - Stop Use

  • Stop use and ask a doctor: If condition worsens or if pain persists for more than 7 days, or clears up, then reoccurs within a few days.

Directions

  • Use only as directedDo not use on children under 12 years of ageRoll onto affected area no more than four times dailyShake well before each use.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camphor, Carbomer, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis Extract, Isopropyl Alcohol, Methyl Sulfonylmethane, Peppermint Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Purified Water, Triethanolamine

* Please review the disclaimer below.