NDC 65121-498 Corisin Arthritis Pain Relief
Capsaicin, Menthol Gel Topical

Product Information

Corisin Arthritis Pain Relief is a human over the counter drug product labeled by Pure Source, Llc. The generic name of Corisin Arthritis Pain Relief is capsaicin, menthol. The product's dosage form is gel and is administered via topical form.

Product Code65121-498
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.
Corisin Arthritis 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.
Capsaicin, 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.
Pure Source, Llc
Labeler Code65121
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.
04-21-2014
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.
12-31-2023
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 Corisin Arthritis Pain Relief?


Product Packages

NDC 65121-498-01

Package Description: 1 BOTTLE in 1 BOX > 28.3 g in 1 BOTTLE

Product Details

What are Corisin Arthritis 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.

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:
  • RxCUI: 1534818 - CORISIN Arthritis Pain Relief 0.025 % / 10 % Topical Gel
  • RxCUI: 1534818 - capsaicin 0.00025 MG/MG / menthol 0.1 MG/MG Topical Gel [Corisin]
  • RxCUI: 1534818 - Corisin Arthritis Pain Relief (capsaicin 0.025 % / menthol 10 % ) Topical Gel
  • RxCUI: 855923 - capsaicin 0.025 % / menthol 10 % Topical Gel
  • RxCUI: 855923 - capsaicin 0.00025 MG/MG / menthol 0.1 MG/MG Topical Gel

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.
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TROLAMINE (UNII: 9O3K93S3TK)

* Please review the disclaimer below.

Corisin Arthritis Pain Relief Labeling and Warnings

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.

Table of Contents



Corisin Arthritis Pain Relief Gel





Active Ingredient



Capsaicin 0.025%
Menthol 10%


Purpose



Topical Analgesic


Uses



For temporary relief of minor aches and pains associated with

  • Simple back ache
  • Arthritis
  • Sprains
  • Cramps

For External Use Only





When Using This Product



  • Read inside of carton before using
  • Use only as directed
  • Do not bandage tightly or cover treated areas
  • Do not use with heating pad
  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds or damaged, broken or irritated skin
  • A mild burning sensation may occur.  If severe burning sensation occurs, discontinue use immediately
  • If symptoms persist for more than seven days, discontinue and consult physician

Keep Out Of Reach Of Children



If swallowed, consult physician


If Pregnant Or Breast Feeding



contact physician prior to use.


Directions




Adult and children over 18 years:

  • Apply directly to effected area.  Repeat as necessary, but do not use more than 3-4 times daily.

Other Ingredients



Allantoin, Aloe Barbadensis (Aloe Vera) Juice, Aqua (Deionized Water), Carbomer, DMDM Hydrantoin, Glycerin, Methyl Paraben, Polysorbate-20, Propyl Paraben, Glycol, Triethanolamine.


* Please review the disclaimer below.