NDC 73126-001 Hemp The Point

Eucalyptus Globulus, Menthol

NDC Product Code 73126-001

NDC Product Information

Hemp The Point with NDC 73126-001 is a a human over the counter drug product labeled by Lab-clean, Llc. The generic name of Hemp The Point is eucalyptus globulus, menthol. The product's dosage form is oil and is administered via topical form.

Labeler Name: Lab-clean, Llc

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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 The Point 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.

  • EUCALYPTUS GUM 20 mg/g
  • MENTHOL 20 mg/g

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.

  • WATER (UNII: 059QF0KO0R)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: Lab-clean, Llc
Labeler Code: 73126
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: 07-03-2019 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: 12-31-2020 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.

Hemp The Point Product Label Images

Hemp The Point 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

Eucalyptus Globulus                                                             Cooling ReliefMenthol                                                                               Muscle Recovery

Uses

Helps relax and recover tensed-up or sore muscles post-workout / also ideal for general daily use for therapeutic relief on the body / the combination of active ingredients helps soothe and moisturize the skin.

Directions

SHAKE WELL BEFORE USEApply as needed on the affected area to relieve muscle tension. Rub with hand post application to help product seep into skin. Ideal for daily use

Warnings

External use only / KEEP OUT OF REACH OF CHILDREN / Ask a doctor prior to use if you: have sensitive skin, are pregnant or breastfeeding, or plan to use on children <2 years old / Do not get in eyes, wounds or damaged skin / Stop immediately if condition worsens andconsult with doctor.

Inactive Ingredients

Water 7732-18-5, Sunflower Oil 8001-21-6, Glycerine 56-81-5, Hemp Seed Oil 8016-24-8,Emulsifier 3055-97-8, Phenoxyethanol, Ethylhexylglycerine 122-99-6 and 70445-33-9.

* Please review the disclaimer below.

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