Stopain Clinical Migraine And Headache

Menthol, Unspecified Form, Atropa Belladonna, Iris Versicolor Root, Sanguinaria Canadensis Root

Troy Manufacturing, Inc.
Human Otc Drug
NDC 63936-9700

Stopain Clinical Migraine And Headache also known as Menthol, Unspecified Form, Atropa Belladonna, Iris Versicolor Root, Sanguinaria Canadensis Root is a human otc drug labeled by 'Troy Manufacturing, Inc.'. National Drug Code (NDC) number for Stopain Clinical Migraine And Headache is 63936-9700. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Stopain Clinical Migraine And Headache drug includes Atropa Belladonna - 3 [hp_X]/g Iris Versicolor Root - 6 [hp_X]/g Menthol, Unspecified Form - 1 [hp_X]/g Sanguinaria Canadensis Root - 6 [hp_X]/g . The currest status of Stopain Clinical Migraine And Headache drug is Active.

Drug Information:

Drug NDC:	63936-9700
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:	Stopain Clinical Migraine And Headache
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:	Menthol, Unspecified Form, Atropa Belladonna, Iris Versicolor Root, Sanguinaria Canadensis Root
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Troy Manufacturing, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
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:	ATROPA BELLADONNA - 3 [hp_X]/g IRIS VERSICOLOR ROOT - 6 [hp_X]/g MENTHOL, UNSPECIFIED FORM - 1 [hp_X]/g SANGUINARIA CANADENSIS ROOT - 6 [hp_X]/g
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:	UNAPPROVED HOMEOPATHIC
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:	01 Jul, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 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.
Listing Expiration Date:	31 Dec, 2024
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:	Troy Manufacturing, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	WQZ3G9PF0H X43D4L3DQC L7T10EIP3A N9288CD508
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
63936-9700-1	12 PACKET in 1 BOX (63936-9700-1) / 1 g in 1 PACKET	01 Jul, 2018	N/A	No
63936-9700-2	1 g in 1 PACKET (63936-9700-2)	30 Sep, 2022	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

Stopain Clinical Migraine And Headache

Menthol & more..

Gel
Troy Manufacturing, Inc.
NDC: 63936-9700

Purpose:

Purpose frontal headache temple/occiput pain sick headache back of head pain

Product Elements:

Stopain clinical migraine and headache menthol, unspecified form, atropa belladonna, iris versicolor root, sanguinaria canadensis root hydroxypropyl cellulose, unspecified pentylene glycol trolamine water menthol, unspecified form menthol atropa belladonna atropa belladonna iris versicolor root iris versicolor root sanguinaria canadensis root sanguinaria canadensis root

Indications and Usage:

Uses temporarily relieves head pain associated with migraine and headache.

Warnings:

Warnings for external use only. this product should not be used topically on children younger than 2 years of age nor should it be applied on any mucus membranes of any age child or adult. seek the advice of your healthcare professional before using this product topically on children 2-12 years of age. avoid contact with eyes. if gel gets in eyes or on muscus membranes flush with cool water for 1-2 minutes ask a doctor before use if you have never had migraines diagnosed by a health professional â¢ do not apply to broken or irritated skin â¢ do not apply to forehead or temples keep out of reach of children. if swallowed, get medicial help or contact a poison control center. stop use and consult a doctor if â¢ condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days â¢ redness is present â¢ excessive irritation of the skin occurs if pregnant or breast feeding ask a health professional before use.

Dosage and Administration:

Directions â¢ adults and children over 12 years: tear open packe â¢ dispense product onto finger tips â¢ apply to back of neck and behind each ear until product is absorbed â¢ use entire contents of packet â¢ for best results, apply as soon as you feel discomfort â¢ if after 30 minutes the symptoms persist, apply second packet

Stop Use:

Stop use and consult a doctor if â¢ condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days â¢ redness is present â¢ excessive irritation of the skin occurs

Package Label Principal Display Panel:

Package labeling:63936-9700-1 label label2

Package labeling: 63936-9700-2 label01

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.