NDC 65121-498 Corisin Arthritis Pain Relief

Capsaicin, Menthol

NDC Product Code 65121-498

NDC 65121-498-01

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

NDC Product Information

Corisin Arthritis Pain Relief with NDC 65121-498 is a 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.

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.

Corisin Arthritis Pain Relief 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.

  • 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)

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: Pure Source, Llc
Labeler Code: 65121
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: 04-21-2014 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".

* Please review the disclaimer below.

Corisin Arthritis Pain Relief Product Label Images

Corisin Arthritis Pain Relief 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

Active Ingredient

Capsaicin 0.025%


Menthol 10%

Purpose

Topical Analgesic

Uses

  • For temporary relief of minor aches and pains associated with
  • Simple back acheArthritisSprainsCramps

When Using This Product

  • Read inside of carton before usingUse only as directedDo not bandage tightly or cover treated areasDo not use with heating padAvoid contact with eyes and mucous membranesDo not apply to wounds or damaged, broken or irritated skinA mild burning sensation may occur.  If severe burning sensation occurs, discontinue use immediatelyIf 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.