NDC 73002-342 Pain Relief Menthol And Hemp

Hemp Extract (cannabis Sativa) 1x, Menthol (mentholum) Tinc.

NDC Product Code 73002-342

NDC CODE: 73002-342

Proprietary Name: Pain Relief Menthol And Hemp What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hemp Extract (cannabis Sativa) 1x, Menthol (mentholum) Tinc. What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 73002 - Green Earth Health Inc.

NDC 73002-342-02

Package Description: 56 mL in 1 BOTTLE

NDC Product Information

Pain Relief Menthol And Hemp with NDC 73002-342 is a a human over the counter drug product labeled by Green Earth Health Inc.. The generic name of Pain Relief Menthol And Hemp is hemp extract (cannabis sativa) 1x, menthol (mentholum) tinc.. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Green Earth Health Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Pain Relief Menthol And Hemp 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.

  • LEVOMENTHOL 10 mg/mL
  • CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP 15.7 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.

  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • LAURETH-7 (UNII: Z95S6G8201)
  • POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EDETATE SODIUM (UNII: MP1J8420LU)

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: Green Earth Health Inc.
Labeler Code: 73002
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 09-01-2020 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.

Pain Relief Menthol And Hemp Product Label Images

Pain Relief Menthol And Hemp 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

Hemp extract (Cannabis sativa) 1X 7%(15.7mg) HPUS                          Anti-inflammatoryMenthol (Mentholum) Tinc. 1% (10mg) HPUS                                       AnalgesicApproximately 56 applications per containerReference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Indication:

Temporarily relieves pain associated with arthritis, joint pain and muscle cramps

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.

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)

Other Information:

• Consult a medical professional if using other medications for known interactions.• Cannabidiol in hemp extract may alter the metabolism of other drugs.

Inactive Ingredients:

Ethylglycerin, C13-14 isoparaffin, laureth-7, phenoxyethanol, polyacrylamide, purified water, tetrasodium EDTA, virgin olive oil, vitamin E

* Please review the disclaimer below.