Pain Relief Menthol And Hemp
Hemp Extract (cannabis Sativa) 1x, Menthol (mentholum) Tinc.
Green Earth Health Inc.
Human Otc Drug
NDC 73002-342Pain Relief Menthol And Hemp also known as Hemp Extract (cannabis Sativa) 1x, Menthol (mentholum) Tinc. is a human otc drug labeled by 'Green Earth Health Inc.'. National Drug Code (NDC) number for Pain Relief Menthol And Hemp is 73002-342. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Pain Relief Menthol And Hemp drug includes Cannabis Sativa Subsp. Sativa Flowering Top - 15.7 mg/mL Levomenthol - 10 mg/mL . The currest status of Pain Relief Menthol And Hemp drug is Active.
Drug Information:
| Drug NDC: | 73002-342 |
| 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: | Pain Relief Menthol And Hemp |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | Hemp Extract (cannabis Sativa) 1x, Menthol (mentholum) Tinc. |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Green Earth Health Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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: | CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP - 15.7 mg/mL
LEVOMENTHOL - 10 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: | UNAPPROVED HOMEOPATHIC |
| 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: | 01 Sep, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| 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. |
| 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: | Green Earth Health Inc.
|
| 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: | 8X454SZ22D
BZ1R15MTK7
|
| 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 |
|---|
| 73002-342-02 | 56 mL in 1 BOTTLE (73002-342-02) | 01 Sep, 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:
Product Elements:
Pain relief menthol and hemp hemp extract (cannabis sativa) 1x, menthol (mentholum) tinc. c13-14 isoparaffin laureth-7 polyacrylamide (crosslinked; 0.01-0.2 mole percent bisacrylamide) olive oil .alpha.-tocopherol water phenoxyethanol ethylhexylglycerin edetate sodium levomenthol levomenthol cannabis sativa subsp. sativa flowering top cannabis sativa subsp. sativa flowering top
Indications and Usage:
Indication: temporarily relieves pain associated with arthritis, joint pain and muscle cramps
Warnings:
Warnings: ⢠for external use only . not for use on open wounds. ⢠if symptoms persist or worsen, discontinue use, seek medical attention. ⢠avoid contact with eyes. if product gets into eyes, flush with water, seek medical attention. ⢠if rash, redness, irritation or itching occurs, discontinue use. ⢠if pregnant or breastfeeding ask a health professional before use. ⢠if swallowed, get medical help or contact a poison center. ⢠keep out of reach of children.
Dosage and Administration:
Directions for use: liberally apply lotion to affected area and rub into joints. use 3-4 times per day for the first week. use as needed thereafter to relieve discomfort. use no more than 4 times per day. allow several days for product to take maximum effect. use within 60 days from opening. store at 50° to 75°f (10°c to 24°c)
Package Label Principal Display Panel:
Product label image description