NDC 51151-129 Hempcin Pain Relief

Menthol

NDC Product Code 51151-129

NDC 51151-129-00

Package Description: 1 TUBE in 1 BOX > 60 g in 1 TUBE

NDC Product Information

Hempcin Pain Relief with NDC 51151-129 is a a human over the counter drug product labeled by Pedicis Research, Llc. The generic name of Hempcin Pain Relief is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Pedicis Research, Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Hempcin Pain Relief 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 50 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)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CHINESE CINNAMON OIL (UNII: A4WO0626T5)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • LAURETH-7 (UNII: Z95S6G8201)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Pedicis Research, Llc
Labeler Code: 51151
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: 03-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Hempcin Pain Relief Product Label Images

Hempcin Pain Relief 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 Ingredient:

Menthol 5%

Purpose

Pain Relieving Cream

Uses:

For the temporary relief of minor aches and pain of muscles and joints

Warnings:

  • For External Use onlyAvoid contact with the eyes Do not apply to wounds or damaged skin Do not bandage tightlyCap tube tightly and store at room temperature away from heat

When Using This Product:

  • Do not use in large quantities particularly over raw surfaces or blistered areasdo not exceed recommended doses unless recommended by a doctor

Stop Use And Ask A Doctor If:

  • Allergic reaction occurs condition worsens or does not improve within 7 dayssymptoms clear up and do not return within a few daysyou notice any unusual effects

Keep Out Of The Reach Of Children:

If swallowed get medical help or call a Poison Control Center right away

Directions:

  • Adults or children 2 years of age and older. Apply externally to affected area not more than 3-4 times daily.Children under 2 years of age consult a doctor

Other Ingredients:

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabis Sativa (Hemp) Seed Oil, Cassia Oil, Cetearyl Alcohol, Dimethyl Sulfone (DMSO), Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Ilex Paraguariensis (Yerba Mate’) Extract, C13-14 Isoparaffin, Isopropyl Alcohol, Laureth-7, Magnesium Sulfate, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

Questions:

Call toll free 1-800-748-6539

* Please review the disclaimer below.