Wellpatch Warming Pain Relief
Capsaicin
The Mentholatum Company
Human Otc Drug
NDC 10742-8127Wellpatch Warming Pain Relief also known as Capsaicin is a human otc drug labeled by 'The Mentholatum Company'. National Drug Code (NDC) number for Wellpatch Warming Pain Relief is 10742-8127. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Wellpatch Warming Pain Relief drug includes Capsaicin - 25 mg/1 . The currest status of Wellpatch Warming Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 10742-8127 |
| 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: | Wellpatch Warming Pain Relief |
| 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: | Capsaicin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | The Mentholatum Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Patch |
| 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 - 25 mg/1
|
| 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: | 05 Dec, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 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, 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: | The Mentholatum Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1043399
1045382
|
| 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
|
| 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 |
|---|
| 10742-8127-1 | 1 PATCH in 1 POUCH (10742-8127-1) | 05 Dec, 2016 | N/A | No |
| 10742-8127-2 | 4 PATCH in 1 POUCH (10742-8127-2) | 05 Dec, 2016 | 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 capsaicin - topical analgesic
Product Elements:
Wellpatch warming pain relief capsaicin carboxymethylcellulose sodium, unspecified form castor oil dihydroxyaluminum aminoacetate edetate disodium glycerin methylparaben polyacrylic acid (250000 mw) polysorbate 80 polyvinyl alcohol, unspecified propylene glycol caprylate water sodium polyacrylate (8000 mw) sorbitol talc tartaric acid capsaicin capsaicin
Indications and Usage:
Uses temporarily relieves minor aches and pains of muscles and joints due to simple backache arthritis strains sprains
Warnings:
Warnings for external use only use only as directed do not use at least 1 hours before, or immediately after, a bath or shower avoid contact with eyes and mucous membranes do not apply to wounds or to damaged or very sensitive skin do not bandage tightly or use with a heating pad stop use and ask a doctor if condition worsens excessive redness, irritation, burning or discomfort of the skin develops symptoms persist for more than 7 days or clear up and occur again within a few days keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily children under 12 years: ask a doctor for best results: apply to clean, dry skin tear open pouch and remove patch; if desired, cut patch to size grasp both ends of the patch firmly with thumbs near center stretch patch until the backing separates remove protective film while applying patch directly to site of pain wash hands with soap and water after applying
Stop Use:
Stop use and ask a doctor if condition worsens excessive redness, irritation, burning or discomfort of the skin develops symptoms persist for more than 7 days or clear up and occur again within a few days
Package Label Principal Display Panel:
Package/label principal display panel wellpatch warming pain relief patch
Principal display panel drug facts
Further Questions:
Questions or comments? toll free 1-877-636-2677 mon-fri 9 am to 5 pm (est)