NDC 79400-101 Modere Sports Rub

Menthol 5%

NDC Product Code 79400-101

NDC 79400-101-01

Package Description: 125 mL in 1 TUBE

NDC Product Information

Modere Sports Rub with NDC 79400-101 is a a human over the counter drug product labeled by Maple Mountain Group, Inc.. The generic name of Modere Sports Rub is menthol 5%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Maple Mountain Group, Inc.

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.

Modere Sports Rub 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/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.

  • AMERICAN GINSENG (UNII: 8W75VCV53Q)
  • TABASCO PEPPER (UNII: J1M3NA843L)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CORN OIL (UNII: 8470G57WFM)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
  • COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • LYSINE ASPARTATE (UNII: 23227F83U0)
  • ISOPENTYLDIOL (UNII: 19NOL5474Q)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • SODIUM BEHENOYL LACTYLATE (UNII: B2LDE4QGZY)
  • TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)

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: Maple Mountain Group, Inc.
Labeler Code: 79400
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: 05-17-2021 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.

Modere Sports Rub Product Label Images

Modere Sports Rub 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

Menthol 5%..............Topical analgesic

Uses

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains

Warnings

For external use only

Otc - When Using

  • When using this productavoid contact with eyes or on mucous membranesdo not apply to wounds or to damaged or very sensitive skindo not bandage tightly or use with a heating pad

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 days or clear up and occur again within a few daysredness is present or irritation develops

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, contact physician prior to use.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Adults and children 12 years and over: Apply to affected area not more than three to four times daily
  • Children under 12 years: consult a physician

Inactive Ingredients

Water, butylene glycol, isopentyldiol, stearic acid, cetyl alcohol, sodium behenoyl lactylate, glycerin, cetearyl alcohol, copaifera officinalis (balsam copaiba) resin oil, dimethyl sulfone, zea mays (corn) oil, lysine aspartate, mentha piperita (peppermint) oil, cetyl hydroxyethylcellulose, cetearyl glucoside, potassium sorbate, stearyl glycyyrrhetinate, 1,2-hexanediol, caprylyl glycol, tetrasodium glutamate diacetate, salix alba (willow) bark extract, yeast polysaccharides, arnica montana flower extract, panax ginseng root extract, panax quinquefolius root extract, capsicum frutescens fruit extract

* Please review the disclaimer below.