NDC 73672-986 Sports Pain Relief Balm

Menthol 4%

NDC Product Code 73672-986

NDC 73672-986-40

Package Description: 1 CONTAINER in 1 CARTON > 40 g in 1 CONTAINER

NDC Product Information

Sports Pain Relief Balm with NDC 73672-986 is a a human over the counter drug product labeled by Metacan Inc Ste. The generic name of Sports Pain Relief Balm is menthol 4%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Metacan Inc Ste

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.

Sports Pain Relief Balm 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 40 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.

  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • TURMERIC (UNII: 856YO1Z64F)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • BLACK PEPPER OIL (UNII: U17J84S19Z)
  • CLOVE OIL (UNII: 578389D6D0)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • WATER (UNII: 059QF0KO0R)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • JOJOBA OIL (UNII: 724GKU717M)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • HEMP (UNII: TD1MUT01Q7)
  • PAPRIKA (UNII: X72Z47861V)

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: Metacan Inc Ste
Labeler Code: 73672
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: 02-10-2020 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.

Sports Pain Relief Balm 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 4%

Purpose

Menthol 4%......................Topical Analgesic

Uses

  • For the temporary relief of minor aches and pains of muslces and joints associated withsimple backachearthritisstrainsbruisessprains

Warnings

For external use only

Otc - When Using

  • When using this productavoid contact with eyesdo not apply to wounds or damaged skindo not bandage tightly

Otc - Stop Use

  • Stop use and ask doctor ifcondition worsensirritation occurssymptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 12 years of age: consult a doctor.

Other Information

  • Store in a cool dry place away from light

Inactive Ingredients

Organic shea (butyrospermum parkii) butter, organic carnauba (copernicia cerifera) wax, peppermint (mentha piperita) leaf oil, organic sunflower (helianthus annuus) seed oil, organic jojoba (simmondsia chinensis) seed oil, organic coconut (cocos nucifera) oil, cetearyl olivate, sorbitan olivate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, pepper (capsicum annuum) fruit extract, organic turmeric (cucuma longa) root oil, water (aqua), glycerin, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, organic rosemary (rosmarinus officinalis) leaf oil, organic eucalyptus (eucalyptus globulus) leaf oil, magnesium sulfate

Otc - Questions

Manufactured for HempFusion
3820 NW 14th Street Suite A & BTopeka, KS 66618877.NOW.HEMP (877.669.4367)hempfusion.com

* Please review the disclaimer below.