NDC 73278-101 Total Muscle Relief

Menthol, Camphor

NDC Product Code 73278-101

NDC 73278-101-13

Package Description: 90 mL in 1 BOTTLE

NDC Product Information

Total Muscle Relief with NDC 73278-101 is a a human over the counter drug product labeled by Nemadji Management Llc. The generic name of Total Muscle Relief is menthol, camphor. The product's dosage form is gel and is administered via topical form.

Labeler Name: Nemadji Management Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Total Muscle 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 3.9 g/100mL
  • CAMPHOR OIL .4 g/100mL

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)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • HEMP (UNII: TD1MUT01Q7)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • SAGE (UNII: 065C5D077J)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • 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.
  • 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: Nemadji Management Llc
Labeler Code: 73278
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: 02-16-2019 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.

Total Muscle 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 Ingredients

MENTHOL  3.9%cAMPHOR  0.4%

Purpose

TOPICAL ANALGESIC

Warnings

EXTERNAL USE ONLY

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Uses

TOPICAL RELIEF MUSCLE GEL

Directions

FOR ADULTS AND CHILDREN 2 YEARS AND OLDER. ROLL GEL ONTO AFFECTED AREA, REPEAT AS NEEDED. APPLICATIONS MAY BE REPEATED UP TO 4X DAILY OR AS DIRECTED BY A CARE PROVIDER. FOR CHILDREN UNDER 2 YEARS OF AGE, CONSULT A MEDICAL PROFESSIONAL.

Inactive Ingredients

PURIFIED WATER, ISOPROPYL ALCOHOL, EXTRACT OF ALOE VERA, HEMP GLOWER OIL, WITCH HAZEL AND SAGE, PROPYLENE GLYCOL, GLYCERIN, COCONUT OIL, SWEET ALMOND OIL, DIMETHICONE COPOLYOL SILICA, CARBOMER, TRIETHANOLAMINE, DMDM HYDANTOIN

* Please review the disclaimer below.