NDC 24909-011 Myco Clinic Pain Relief
Camphor, Menthol Oil Topical

Product Information

What is NDC 24909-011?

The NDC code 24909-011 is assigned by the FDA to the product Myco Clinic Pain Relief which is a human over the counter drug product labeled by Aidance Skincare & Topical Solutions, Llc. The generic name of Myco Clinic Pain Relief is camphor, menthol. The product's dosage form is oil and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 24909-011-10 100 ml in 1 bottle , 24909-011-25 250 ml in 1 bottle . 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 Code24909-011
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.		Myco Clinic Pain Relief
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.		Camphor, 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.		Camphor (natural); 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 FormOil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
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.		Aidance Skincare & Topical Solutions, Llc
Labeler Code24909
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.		02-24-2023
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 Myco Clinic Pain Relief?


Product Packages

NDC Code 24909-011-10

Package Description: 100 mL in 1 BOTTLE

NDC Code 24909-011-25

Package Description: 250 mL in 1 BOTTLE

Product Details

What are Myco Clinic Pain Relief 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.

Myco Clinic Pain Relief 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:

Myco Clinic Pain Relief 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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Myco Clinic Pain Relief 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             Purpose



Camphor USP, 3.1%.......Topical analgesic
Menthol USP, 7%.......Topical analgesic


Uses



temporarily relieves minor aches and pain of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains


Warnings



For external use only


Do not use on wounds or damaged skin


When using this product avoid contact with eyes or mucous membranes - do not bandage tightly or use with a heating pad


Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, excessive skin irritation develops


If pregnant or breastfeeding, ask a health professional before use.


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


Directions



Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Wash hands with soap and water after use (unless applying to hands)
children under 12 years of age: ask a doctor


Inactive Ingredients



Arnica Extract, Ginger Extract, Honeysuckle Oil, Jojoba Oil, MCT/Coconut Oil, Mushroom Extracts - USDA Organic (Cordyceps, Lion's Mane, Reishi, Shiitake), Sweet Orange Oil, Turmeric Extract


Questions?



myco-clinic.com
Questions? 401-671-6170


Product Label



image description - Label 250ml Updated

image description - Label 250ml Updated


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