Capsimide
Capsaicin 0.025% Topical Patch
Sola Pharmaceuticals
Human Otc Drug
NDC 70512-016Capsimide also known as Capsaicin 0.025% Topical Patch is a human otc drug labeled by 'Sola Pharmaceuticals'. National Drug Code (NDC) number for Capsimide is 70512-016. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Capsimide drug includes Capsaicin - .025 g/100g . The currest status of Capsimide drug is Active.
Drug Information:
| Drug NDC: | 70512-016 |
| 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: | Capsimide |
| 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 0.025% Topical Patch |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sola Pharmaceuticals |
| 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 - .025 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: | 07 Sep, 2022 |
| 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. |
| 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: | Sola Pharmaceuticals
|
| 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. |
| UPC: | 0070512016103
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 70512-016-10 | 10 POUCH in 1 BOX (70512-016-10) / 9 g in 1 POUCH | 07 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. |
Purpose:
Purpose topical analgesic
Product Elements:
Capsimide capsaicin 0.025% topical patch propylene glycol hydroxyacetophenone water dihydroxyaluminum aminoacetate edetate disodium kaolin carboxymethylcellulose sodium capsaicin capsaicin sodium polyacrylate (8000 mw) povidone titanium dioxide tartaric acid polyacrylic acid (8000 mw) polysorbate 80 isopropyl myristate glycerin
Indications and Usage:
Uses temporarily relieves minor pain.
Warnings:
Warnings for external use only
Do Not Use:
Warnings for external use only
When Using:
When using this product use only as directed read and follow all directions and warnings on this carton do not allow contact with the eyes do not sue at the same time as other topical analgesics do not bandage tightly or apply local heat (such as heating pads) to the area of use do not microwave dispose of used patch in a manner that always keeps product away from children and pets. used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Dosage and Administration:
Directions adults and children 12 years of age and over: clean and dry affected area. carefully remove backing from patch starting at a corner. apply sticky side of patch to affected area. use one patch for up to 12 hours. discard patch after single use. children under 12 years of age: consuly a physician.
Stop Use:
Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.
Package Label Principal Display Panel:
Manufactured for: sola pharmaceuticals llc baton rouge, la 70810 www.solameds.us made in china capsimide patch ndc 70512-016-10 qty: 10 patches (1 per pouch) x 10 capsimide pouch capsimide box
Further Questions:
Questions or comments? 866-747-7365