NDC 72667-021 Myderm Cooling Menthol Pain Relief With 50 Percent More Menthol

Menthol

NDC Product Code 72667-021

NDC CODE: 72667-021

Proprietary Name: Myderm Cooling Menthol Pain Relief With 50 Percent More Menthol 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: 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.
    • 72667-021 - Myderm Cooling Menthol Pain Relief With 50 Percent More Menthol

NDC 72667-021-01

Package Description: 89 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Myderm Cooling Menthol Pain Relief With 50 Percent More Menthol with NDC 72667-021 is a a human over the counter drug product labeled by Inspec Solutions Llc.. The generic name of Myderm Cooling Menthol Pain Relief With 50 Percent More Menthol is menthol. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 415976.

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.

Myderm Cooling Menthol Pain Relief With 50 Percent More Menthol 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.


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.

  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • WATER (UNII: 059QF0KO0R)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • FRANKINCENSE (UNII: R9XLF1R1WM)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: 12-27-2021 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".

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Myderm Cooling Menthol Pain Relief With 50 Percent More Menthol Product Label Images

Myderm Cooling Menthol Pain Relief With 50 Percent More Menthol 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 4%

Otc - Purpose

Menthol 4% ........... Topical analgesic

Indications & Usage

Uses Temporary relief of pain

Warnings

For external use only

Otc - When Using

DO not use in large quantities over raw surfaces and blistered areaWhen using this productUse only as directed, read and follow all directions and warnings on this label, rare cases of serious burn have been reported with product of this type, do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with medicated patch, avoid contact with eyes and mucous membranes

Otc - Stop Use

Stop use and ask doctor if, condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days.

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.

Dosage & Administration

Directionsadults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.

Inactive Ingredient

Inactive ingredientsAloe Barbadensis Leaf ExtractArctium Lappa Root (Burdock) ExtractArnica Montana Flower ExtractBoswellia Carterii Resin ExtractCalendula Officinalis ExtractCamellia Sinensis Leaf ExtractCamphorCarbomer FD&C Blue #1FD&C Yellow #5Full Spectrum Industrial Hemp ExtractGlycerinIlex Paraguariensis (Mate) Leaf ExtractIsopropyl AlcoholIsopropyl MyristateMelissa Officinalis (Lemon Balm) Leaf ExtractSilicaTocopheryl AcetateTriethanolamineWater

* Please review the disclaimer below.