Nufabrx Hand/wrist Sleeve
Capsaicin
Textile-based Delivery, Inc.
Human Otc Drug
NDC 72490-014Nufabrx Hand/wrist Sleeve also known as Capsaicin is a human otc drug labeled by 'Textile-based Delivery, Inc.'. National Drug Code (NDC) number for Nufabrx Hand/wrist Sleeve is 72490-014. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Nufabrx Hand/wrist Sleeve drug includes Capsaicin - .23 g/100g . The currest status of Nufabrx Hand/wrist Sleeve drug is Active.
Drug Information:
| Drug NDC: | 72490-014 |
| 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: | Nufabrx Hand/wrist Sleeve |
| 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: | Textile-based Delivery, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cloth |
| 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 - .23 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 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Dec, 2025 |
| 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: | Textile-Based Delivery, 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: | 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 |
|---|
| 72490-014-10 | 1 g in 1 BOX (72490-014-10) | 11 May, 2020 | 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:
Nufabrx hand/wrist sleeve capsaicin butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) capsaicin capsaicin
Indications and Usage:
Uses for the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, and sprains.
Warnings:
Warnings for external use only do not use if you are allergic to any ingredients of this product or chili peppers contact a doctor before use (allergy alert) on wounds or to damaged skin with, or at same time as, other external analgesic products with a heating pad when using this product you may experience a burning sensation which is normal and related to the way the product works (with regular use, this sensation generally diminishes) do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise use only as directed avoid contact with eyes and mucous membranes or rashes stop use and ask a doctor if condition worsens, symptoms persist more than 7 days or clear up and occur again within a few days rash, itching or excessive skin irritation develops if pregnant or breastfeeding consult a healthcare professional before use keep out of reach of children if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only do not use if you are allergic to any ingredients of this product or chili peppers contact a doctor before use (allergy alert) on wounds or to damaged skin with, or at same time as, other external analgesic products with a heating pad when using this product you may experience a burning sensation which is normal and related to the way the product works (with regular use, this sensation generally diminishes) do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise use only as directed avoid contact with eyes and mucous membranes or rashes stop use and ask a doctor if condition worsens, symptoms persist more than 7 days or clear up and occur again within a few days rash, itching or excessive skin irritation develops if pregnant or breastfeeding consult a healthcare professional before use keep out of reach of children if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product you may experience a burning sensation which is normal and related to the way the product works (with regular use, this sensation generally diminishes) do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise use only as directed avoid contact with eyes and mucous membranes or rashes
Dosage and Administration:
Directions clean and dry affected area remove sleeve from packaging and place on wrist maximum use of 8 hours per day (remove after 8 hours of wear) wash separately from other clothing do not wear more than 6 days straight without doctor consent
Stop Use:
Stop use and ask a doctor if condition worsens, symptoms persist more than 7 days or clear up and occur again within a few days rash, itching or excessive skin irritation develops
Package Label Principal Display Panel:
Principal display panel entire label