NDC 61577-4030 Sombra Cool Therapy
Menthol Gel Topical

Product Information

What is NDC 61577-4030?

The NDC code 61577-4030 is assigned by the FDA to the product Sombra Cool Therapy which is a human over the counter drug product labeled by Sombra Cosmetics Inc.. The generic name of Sombra Cool Therapy is menthol. The product's dosage form is gel and is administered via topical form. The product is distributed in 6 packages with assigned NDC codes 61577-4030-1 3628.7 g in 1 bottle, pump , 61577-4030-2 907.2 g in 1 bottle, pump , 61577-4030-3 226.8 g in 1 jar , 61577-4030-4 113.4 g in 1 jar , 61577-4030-5 85 g in 1 bottle, plastic , 61577-4030-6 5 g in 1 pouch . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code61577-4030
Proprietary Name 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.		Sombra Cool Therapy
Non-Proprietary Name 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.		Menthol
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Menthol
Product Type 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.		Human Otc Drug
Dosage FormGel - 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.
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.		Sombra Cosmetics Inc.
Labeler Code61577
FDA Application Number 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.		part348
Marketing Category 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.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-03-2023
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Sombra Cool Therapy?


Product Packages

NDC Code 61577-4030-1

Package Description: 3628.7 g in 1 BOTTLE, PUMP

NDC Code 61577-4030-2

Package Description: 907.2 g in 1 BOTTLE, PUMP

NDC Code 61577-4030-3

Package Description: 226.8 g in 1 JAR

NDC Code 61577-4030-4

Package Description: 113.4 g in 1 JAR

NDC Code 61577-4030-5

Package Description: 85 g in 1 BOTTLE, PLASTIC

NDC Code 61577-4030-6

Package Description: 5 g in 1 POUCH

Product Details

What are Sombra Cool Therapy Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Sombra Cool Therapy Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Sombra Cool Therapy Inactive Ingredients UNII Codes

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.

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Sombra Cool Therapy Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients



Menthol USP 6%


Purpose



Purpose
External Analgesic


Keep Out Of Reach Of Children



Keep out of reach of children


Uses



Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches


Warnings



For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.


Directions



adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.


Inactive Ingredients



Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Leaf
Extract, Caprylyl Glycol, Carbomer, Citrus Grandis (Grapefruit) Seed Extract, Citrus Limon
(Lemon) Peel Oil, Decyl Glucoside, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf
Extract, Phenoxyethanol, Purified Water, Rosa Damascena Flower Water, Sodium Carbonate,
Spiraea Ulmaria Flower (Queen of the Prairie) Extract, Yucca Schidigera Root Extract.


Questions Or Comments



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