Fors Pain Relief
Menthol, Capsaicin
Fors Llc
Human Otc Drug
NDC 81765-184Fors Pain Relief also known as Menthol, Capsaicin is a human otc drug labeled by 'Fors Llc'. National Drug Code (NDC) number for Fors Pain Relief is 81765-184. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Fors Pain Relief drug includes Capsaicin - .35 mg/mL Menthol - 40 mg/mL . The currest status of Fors Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 81765-184 |
| 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: | Fors 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: | Menthol, Capsaicin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fors Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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 - .35 mg/mL
MENTHOL - 40 mg/mL
|
| 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 Apr, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Mar, 2023 |
| 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: | 22 Dec, 2025 |
| 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: | FORS LLC
|
| 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. |
| UPC: | 0860006084608
|
| UPC stands for Universal Product Code. |
| UNII: | S07O44R1ZM
L7T10EIP3A
|
| 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 |
|---|
| 81765-184-01 | 1 JAR in 1 BOX (81765-184-01) / 60 mL in 1 JAR | 05 Apr, 2021 | 31 Mar, 2023 | 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:
Fors pain relief menthol, capsaicin carbomer interpolymer type a (allyl sucrose crosslinked) allantoin aloe vera leaf water indian frankincense butylene glycol cannabidiol medium-chain triglycerides polyoxyl 20 cetostearyl ether cetyl alcohol ethylhexylglycerin eucalyptus oil glycerin sodium acryloyldimethyltaurate ilex paraguariensis leaf mineral oil phenoxyethanol polysorbate 20 polysorbate 60 almond oil squalane trolamine .alpha.-tocopherol acetate menthol menthol capsaicin capsaicin
Indications and Usage:
Uses: for the temporary relief of minor aches and pains of muscles and joints, associated with arthritis strains, bruises, and sprains.
Warnings:
Warnings: for external use only do not use on damaged or broken skin. when using this product keep out of eyes. rinse with water to remove. do not bandage tightly. stop use and ask a doctor if rash or irritation develops and lasts. condition worsens, or if 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 poision control center right away. if pregnant or breast-feeding, ask a health professional before use.
Do Not Use:
Warnings: for external use only do not use on damaged or broken skin. when using this product keep out of eyes. rinse with water to remove. do not bandage tightly. stop use and ask a doctor if rash or irritation develops and lasts. condition worsens, or if 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 poision control center right away. if pregnant or breast-feeding, ask a health professional before use.
When Using:
When using this product keep out of eyes. rinse with water to remove. do not bandage tightly.
Dosage and Administration:
Directions: adults and children 2 years of age and older: apply to affected area not ore than 3 to 4 times daily. children under 2 years of age: consult doctor.
Stop Use:
Stop use and ask a doctor if rash or irritation develops and lasts. condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Package Label Principal Display Panel:
Package labeling: label
Further Questions:
Questions? 1-800-210-7924