2-count Heat Patches
Capsaicin
Veridian Healthcare
Human Otc Drug
NDC 71101-9042-count Heat Patches also known as Capsaicin is a human otc drug labeled by 'Veridian Healthcare'. National Drug Code (NDC) number for 2-count Heat Patches is 71101-904. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in 2-count Heat Patches drug includes Capsaicin - .25 g/g . The currest status of 2-count Heat Patches drug is Active.
Drug Information:
| Drug NDC: | 71101-904 |
| 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: | 2-count Heat Patches |
| 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: | Veridian Healthcare |
| 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 g/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: | 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: | 21 Nov, 2018 |
| 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, 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: | Veridian Healthcare
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1043399
|
| 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 |
|---|
| 71101-904-02 | 2 PATCH in 1 BOX (71101-904-02) / 9 g in 1 PATCH | 21 Nov, 2018 | 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 temporary relief of minor pain.
Product Elements:
2-count heat patches capsaicin capsaicin capsaicin hydrogenated polydecene (550 mw) pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) liquid petroleum styrene/acrylamide copolymer (mw 500000)
Indications and Usage:
Uses temporary relief of minor pain associated with: arthiritis minor backache strains sprains bruises
Warnings:
For external use only discontinue use at least one hour prior to bath / shower / swimming; do not use immediatelty after bath / shower / swimming. allergy alert: if you are allergic or suspect you are allergic to the ingredients listed below, including chili perppers.. consults with your physician before use.
Do Not Use:
For external use only discontinue use at least one hour prior to bath / shower / swimming; do not use immediatelty after bath / shower / swimming. allergy alert: if you are allergic or suspect you are allergic to the ingredients listed below, including chili perppers.. consults with your physician before use.
Dosage and Administration:
Directions for use: for use on adults and childrens 12 years of age or older clean and dru affected area; ensure area is fully dry before application remove patch from film apply to treatement site patch may be trimmerd to best fit treatment site; trim patch before removing film wash hands after application discard after signle use caution: take care when using on elderly ot incapacited persons do not use more than 8 hours do not use the capsaicin heat patch more than 3-4 times daily do not exceed 7 days of continue use
Package Label Principal Display Panel:
Label manufactured for: veridian healthcare, llc 1175 lakeside drive gurnee, il 60031 usa made in china capsaicin heat path
Further Questions:
Questions toll-free customer care help line 866-326-1313 mon-fri 8:30 am - 4:30 pm cst