Arth Arrest

Methyl Nicotinate, Capsaicin

Key 2 Health, Inc.
Human Otc Drug
NDC 76018-100

Arth Arrest also known as Methyl Nicotinate, Capsaicin is a human otc drug labeled by 'Key 2 Health, Inc.'. National Drug Code (NDC) number for Arth Arrest is 76018-100. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Arth Arrest drug includes Capsaicin - .025 g/100g Methyl Nicotinate - .5 g/100g . The currest status of Arth Arrest drug is Active.

Drug Information:

Drug NDC:	76018-100
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Arth Arrest
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Methyl Nicotinate, Capsaicin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Key 2 Health, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Cream
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	CAPSAICIN - .025 g/100g METHYL NICOTINATE - .5 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	11 Feb, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	19 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part348
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Key 2 Health, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1091943
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	S07O44R1ZM 7B1AVU9DJN
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Nicotinic Acid [EPC] Nicotinic Acids [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
76018-100-03	85 g in 1 BOTTLE (76018-100-03)	05 Feb, 2017	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Arth Rx Topical Analgesic

Methyl Nicotinate, Capsaicin

Lotion
HCD Sales
NDC: 76069-100

Arth Arrest

Methyl Nicotinate, Capsaicin

Cream
Key 2 Health, Inc.
NDC: 76018-100

Purpose:

Indications for the temporary relief of minor aches and pains of muscles and joints.

Product Elements:

Arth arrest methyl nicotinate, capsaicin isopropyl alcohol water lidocaine hydrochloride polyquaternium-7 (70/30 acrylamide/dadmac; 1600 kd) c13-14 isoparaffin laureth-7 aloe vera leaf arnica montana flower chamomile polysorbate 80 methyl nicotinate niacin capsaicin capsaicin

Indications and Usage:

How to apply: apply to a small area of the skin as a test for sensitivity at least 60 minutes prior to applying to a wide area.

Warnings:

For external use only warnings: use only as directed, avoid contact with eyes. do not apply to wounds or damaged skin. do not bandage tightly. if condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. please see outer box for additional warnings prior to use.

Dosage and Administration:

Directions: adults and children 2 years of age and older. apply to affected area no more than 3-4 times daily. children under 2 years of age consult a physician.

Package Label Principal Display Panel:

Penetrating pain relief double action formula with neurocaine arth arrest net wt. 3 oz (85gm)

Arth arrest

Further Questions:

Questions or comments toll free 1-800-339-3301 www.key2health.com distributed by: key2health inc., tampa, florida 33618

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.