NDC 72667-010 Ultra Strenght Muscle Rub

Methyl Salicylate, Menthol

NDC Product Code 72667-010

NDC Code: 72667-010

Proprietary Name: Ultra Strenght Muscle Rub What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Methyl Salicylate, Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 72667 - Inspec Solutions Llc.
    • 72667-010 - Ultra Strenght Muscle Rub

NDC 72667-010-01

Package Description: 113 mL in 1 TUBE

NDC Product Information

Ultra Strenght Muscle Rub with NDC 72667-010 is a a human over the counter drug product labeled by Inspec Solutions Llc.. The generic name of Ultra Strenght Muscle Rub is methyl salicylate, menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Inspec Solutions 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.

Ultra Strenght Muscle 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, UNSPECIFIED FORM 8 g/100mL
  • METHYL SALICYLATE 30 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.

  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • POTASSIUM STEARATE (UNII: 17V812XK50)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CETYL PHOSPHATE (UNII: VT07D6X67O)
  • WATER (UNII: 059QF0KO0R)
  • LANOLIN (UNII: 7EV65EAW6H)

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: Inspec Solutions Llc.
Labeler Code: 72667
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: 05-07-2019 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.

Ultra Strenght Muscle Rub Product Label Images

Ultra Strenght Muscle 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

Otc - Active Ingredient

Active ingredientMenthol - 8.00% Methyl Salicylate - 30.00%

Otc - Purpose

PurposeMenthol - 8.00% .................................................. External AnalgesicMethyl Salicylate - 30.00% ................................. External Analgesic

Indications & Usage

Uses Temporary relief for minor aches and pains of muscles and joints.

Warnings

WarningsFor external use only, Do not bandage tightly, apply to wounds or damaged skin or use with a heating pad.

Otc - Stop Use

Caution: Discontinue use if excessive irritation of skin develops, Avoid getting into eyes or mucous membranes, If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning, if swallowed, get medical help or contact a poison control center right away.

Dosage & Administration

DirectionsUse only as directed. 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: Ask a doctor.

Inactive Ingredient

DEA-Cetyl PhosphateGlyceryl StearateLanolinPotassium StearateStearic AcidWater

* Please review the disclaimer below.

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