Cbd Menthol Pain Relief Fast Acting Pain Roller
Menthol, Unspecified Form
Global Products Group, Llc
Human Otc Drug
NDC 72593-158Cbd Menthol Pain Relief Fast Acting Pain Roller also known as Menthol, Unspecified Form is a human otc drug labeled by 'Global Products Group, Llc'. National Drug Code (NDC) number for Cbd Menthol Pain Relief Fast Acting Pain Roller is 72593-158. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Cbd Menthol Pain Relief Fast Acting Pain Roller drug includes Menthol, Unspecified Form - 85 mg/mL . The currest status of Cbd Menthol Pain Relief Fast Acting Pain Roller drug is Active.
Drug Information:
| Drug NDC: | 72593-158 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cbd Menthol Pain Relief Fast Acting Pain Roller |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Cbd Menthol Pain Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Fast Acting Pain Roller |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Menthol, Unspecified Form |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Global Products Group, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | MENTHOL, UNSPECIFIED FORM - 85 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 05 Oct, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Global Products Group, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | L7T10EIP3A
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 72593-158-12 | 88 mL in 1 BOTTLE, WITH APPLICATOR (72593-158-12) | 05 Oct, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose topical analgesic
Product Elements:
Cbd menthol pain relief fast acting pain roller menthol, unspecified form menthol, unspecified form menthol, unspecified form aloe vera leaf arnica montana whole indian frankincense camphor (synthetic) cannabis sativa seed oil carbomer interpolymer type a (allyl sucrose crosslinked) chondroitin sulfate (shark) glucosamine sulfate potassium chloride glycerin ilex paraguariensis leaf isopropyl alcohol ethylhexylglycerin phenoxyethanol dimethyl sulfone peppermint oil polysorbate 20 propylene glycol trolamine water
Indications and Usage:
Uses temporarily relieves muscle and joint pain associated with arthritis muscle aches muscle strains joint pain.
Warnings:
Warnings for external use only: flammable: keep away from excessive heat or open flame ask a doctor before use if you have sensitive skin or if you are taking any blood thinners when using this product: do not use on wounds or irritated skin do not bandage tightly or use with a heating pad wash hands after use with cool water if pregnant or breastfeeding: ask a health professional before use keep out of reach of children. if accidentally swallowed, contact a doctor or poison control center immediately 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.
When Using:
When using this product: do not use on wounds or irritated skin do not bandage tightly or use with a heating pad wash hands after use with cool water
Dosage and Administration:
Directions use only as directed do not use on children under 12 years of age roll onto affected area no more than four times daily shake well before each use.
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.
Package Label Principal Display Panel:
Principal display panel - 88 ml bottle label fore 150mg cbd menthol pain relief fast-acting pain roller net wt. 3 fl oz (88 ml) principal display panel - 88 ml bottle label
Further Questions:
Questions or comments? call (877) 383-2334. store in a cool dry place with the cap tightly closed. note: because this product contains natural ingredients, color may vary.