Capsaicin
Forreal Pharmaceuticals Llc
Human Otc Drug
NDC 81877-515Capsaicin is a human otc drug labeled by 'Forreal Pharmaceuticals Llc'. National Drug Code (NDC) number for Capsaicin is 81877-515. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Capsaicin drug includes Capsaicin - .025 g/100g . The currest status of Capsaicin drug is Active.
Drug Information:
| Drug NDC: | 81877-515 |
| 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: | Capsaicin |
| 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: | Forreal Pharmaceuticals Llc |
| 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: | UNAPPROVED DRUG OTHER |
| 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: | 16 Aug, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 04 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. |
| 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: | FORREAL PHARMACEUTICALS LLC
|
| 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 |
|---|
| 81877-515-15 | 15 PATCH in 1 CARTON (81877-515-15) / 100 g in 1 PATCH | 16 Aug, 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 external analgesic
Product Elements:
Capsaicin capsaicin capsaicin capsaicin glycerin sodium polyacrylate (8000 mw) dihydroxyaluminum aminoacetate edetate disodium kaolin carboxymethylcellulose sodium titanium dioxide tartaric acid polyacrylic acid (8000 mw) polysorbate 80 petrolatum hydroxyacetophenone water
Indications and Usage:
Uses temporarily relieves minor aches and pains of muscles and joints due to: ⢠arthritis ⢠simple backache ⢠strains ⢠bruises ⢠sprains
Warnings:
Warnings for external use only . use only as directed or as directed by a health care professional read all warnings and directions before use. discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming. do not use ⢠on wounds, cuts, damaged or infected skin ⢠on eyes, mouth, genitals, or any other mucous membranes allergy alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use. whe n us ing this product ⢠you may experience a burning sensation. the intensity of this reaction varies among individuals and may be severe. with regular use, this sensation generally disappears after several days. ⢠avoid contact with the eyes, lips, nose and mucous membranes ⢠do not tightly wrap or bandage the treated area ⢠do not apply heat to the treated area immediately before or after use stop use and as k a physician: ⢠if pregnan
Read more...t or breast feeding ⢠if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. ⢠if severe burning persists or blistering occurs keep out of reach of children and pets . if swallowed, get medical help or contact a poison control center immediately.
Do Not Use:
Warnings for external use only . use only as directed or as directed by a health care professional read all warnings and directions before use. discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming. do not use ⢠on wounds, cuts, damaged or infected skin ⢠on eyes, mouth, genitals, or any other mucous membranes allergy alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use. whe n us ing this product ⢠you may experience a burning sensation. the intensity of this reaction varies among individuals and may be severe. with regular use, this sensation generally disappears after several days. ⢠avoid contact with the eyes, lips, nose and mucous membranes ⢠do not tightly wrap or bandage the treated area ⢠do not apply heat to the treated area immediately before or after use stop use and as k a physician: ⢠if pregnant or breast feeding ⢠if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. ⢠if severe burning persists or blistering occurs keep out of reach of children and pets . if swallowed, get medical help or contact a poison control center immediately.
When Using:
Whe n us ing this product ⢠you may experience a burning sensation. the intensity of this reaction varies among individuals and may be severe. with regular use, this sensation generally disappears after several days. ⢠avoid contact with the eyes, lips, nose and mucous membranes ⢠do not tightly wrap or bandage the treated area ⢠do not apply heat to the treated area immediately before or after use
Dosage and Administration:
Directions adults and children 18 years of age and older: apply 1 patch to the affected area of intact skin up to 3 times a day. do not leave patch on for more than 8 hours at a time. clean and dry the affected area. open pouch and remove one patch. remove any protective film and apply directly to affected area of pain. apply immediately after removal from the protective envelope. wash hands with soap and water after handling the patches. reseal pouch containing unused patches after each use. do not store patch outside the sealed envelope. fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. children under 18 years : ask a physician
Package Label Principal Display Panel:
Principal display panel ndc 81877-515-15 qty: 15 patches (5 per resealable pouch) x 3 capsaicin 0.025 % topical pain patch for temporary pain relief forreal pharmaceuticals llc principal display panel