NDC 50130-108 Total Muscle Relief

Menthol, Camphor

NDC Product Code 50130-108

NDC 50130-108-13

Package Description: 89 mL in 1 TUBE

NDC 50130-108-16

Package Description: 473 mL in 1 BOTTLE

NDC 50130-108-23

Package Description: 89 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Total Muscle Relief with NDC 50130-108 is a a human over the counter drug product labeled by Electrostim Medical Services Inc. D/b/a Emsi. 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: Electrostim Medical Services Inc. D/b/a Emsi

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 5 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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • WATERCRESS (UNII: K5877MW0LE)
  • ROSEMARY (UNII: IJ67X351P9)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • EMU OIL (UNII: 344821WD61)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)

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: Electrostim Medical Services Inc. D/b/a Emsi
Labeler Code: 50130
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 Ingredient

Menthol ---5.0%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthrilis backaches strains sprains

Warnings

FOR EXTERNAL USE ONLY.FLAMMABLE; KEEP AWAY FROM EXCESSIVE HEAT OR OPEN FLAME.Ask doctor before use if you have: Sensitive skin. When using this product: Avoid contact with the eyes or mucus membranes. Do not apply to wounds or damaged skin. Do not use with other ointments, creams, sprays or liniments. Do not apply to irritated skin of if excessive irritation develpes. Do not bandage. Wash hand after use with cold water. Do not use heating pads or device. Store in a cool dry place.Stop use and ask doctor if: condition worsens or if symptoms percist for more than 7 days or clear up and recur.If pregnant or breast feeding: ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children: if accidently ingested get medical help or contact Poison Control Center immediately.

Directions

ADULT AND CHILDREN 2 YEARS OF AGE AND OLDER: RUB A THIN FILM OVER AFFECTED AREAS NOT MORE THAN 4 TIMES DAILY. MASSAGE NOT NECESSARY.CHILDREN UNDER 2 YEARS OF AGE: CONSULT PHYSICIAN.

Inactive Ingredients

PURIFIED WATER, Extract of Aloe Vera, Witch Hazel, Water Cress and Rosemary, Isopropanol, Glycerin, Coconut Oil, Sweet Almond Oil, Emu Oil, Carbomer, Sodium Hydroxide, Silica, F. D. & C Yellow #5, F. D.& C Blue #1, DMDM Hydantoin

* Please review the disclaimer below.

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