Stopain Cold Pain Relieving
Menthol
Troy Manufacturing, Inc
Human Otc Drug
NDC 63936-8558Stopain Cold Pain Relieving also known as Menthol is a human otc drug labeled by 'Troy Manufacturing, Inc'. National Drug Code (NDC) number for Stopain Cold Pain Relieving is 63936-8558. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Stopain Cold Pain Relieving drug includes Menthol - 60 mg/mL . The currest status of Stopain Cold Pain Relieving drug is Active.
Drug Information:
| Drug NDC: | 63936-8558 |
| 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 Cold Pain Relieving |
| 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 |
| 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: | Spray |
| 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: | MENTHOL - 60 mg/mL
|
| 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: | 13 Oct, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | TROY MANUFACTURING, INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 259550
404694
|
| 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. |
| UPC: | 0724909000014
|
| UPC stands for Universal Product Code. |
| UNII: | L7T10EIP3A
|
| 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 |
|---|
| 63936-8558-1 | 240 mL in 1 BOTTLE, SPRAY (63936-8558-1) | 13 Oct, 2010 | 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. |
Purpose:
Purpose topical analgesic
Product Elements:
Stopain cold pain relieving menthol eucalyptus oil isopropyl alcohol peppermint oil water menthol menthol
Indications and Usage:
Uses: for the temporary relief of minor aches and pains of muscle and joints associated with - simple backache -arthritis - strains - bruises -sprains
Warnings:
Warnings for eternal use only. avoid contact with eyes. flammable: keep away from fire or flame
When Using:
When using this product use only as directed do not bandage tightly or use a heating pad do not apply to wounds or damaged skin.
Dosage and Administration:
Directions adults and children over 12 years: spray directly onto affected area without the need to rub, massage or bandage repeat as necessary, but do not apply more than 4 times daily. children 12 years or younger: ask a doctor.
Stop Use:
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. redness is present excessive irritation of the skin develops.
Package Label Principal Display Panel:
Nothing lasts longer stopain cold no-drip, no-stain pain relieving spray immediate, penetrating pain relief from arthritis muscle aches back pain 8fl oz (240 ml) your purchase benefits the arthritis foundation stopain. exactly what it does. tm sprays at any angle non greasy light, pleasant scent easy to use works on contact pharmacist recommended our pharmacist recommended formulas: work on contact provide long-lasting pain relief for more information, visit www.stopain.com today made in usa to report a serious adverse event, contact (800) 201 pain (7246) your purchase benefits the arthritis foundation for every unit of stopain(r) product sold, troy healthcare, llc will donate a portion of the proceeds to the arthrits foundation with a minimum contribution of $25,000 to help people take control of arthritis. for information about arthritis, contact the foundation at 800-283-7800 or www.arthritis.org.
Stopain 8oz spray