Perform Atomic Heat
Capsaicin, Methyl Salicylate
Performance Health, Llc
Human Otc Drug
NDC 59316-303Perform Atomic Heat also known as Capsaicin, Methyl Salicylate is a human otc drug labeled by 'Performance Health, Llc'. National Drug Code (NDC) number for Perform Atomic Heat is 59316-303. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Perform Atomic Heat drug includes Capsaicin - .3 mg/mL Methyl Salicylate - 100 mg/mL . The currest status of Perform Atomic Heat drug is Active.
Drug Information:
| Drug NDC: | 59316-303 |
| 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: | Perform Atomic Heat |
| 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, Methyl Salicylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Performance Health, 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 - .3 mg/mL
METHYL SALICYLATE - 100 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: | 28 Jul, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 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: | 24 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: | Performance Health, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1802849
|
| 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: | 0731124310002
|
| UPC stands for Universal Product Code. |
| UNII: | S07O44R1ZM
LAV5U5022Y
|
| 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 |
|---|
| 59316-303-10 | 89 mL in 1 BOTTLE, WITH APPLICATOR (59316-303-10) | 28 Jul, 2016 | 31 Dec, 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:
Perform atomic heat capsaicin, methyl salicylate carbomer interpolymer type a (allyl sucrose crosslinked) aminomethyl propanediol cetostearyl alcohol polysorbate 60 ethylhexylglycerin glyceryl monostearate ilex paraguariensis leaf isopentyldiol petrolatum polysorbate 80 vanillyl butyl ether water capsaicin capsaicin methyl salicylate salicylic acid
Indications and Usage:
Uses: for the temporary relief form minor aches & pains of sore muscles & joints associated with arthritis, backache, strains & sprains.
Warnings:
Warnings: for external use only. use only as directed. keep out of reach of children. if accidentally ingested, get medical help or contact a poison control center immediately. this product is intended to & may cause a mild temporary skin irritation. discontinue use if excessive skin irritation develops. when using this product avoid contact with eyes or muccus membranes ⢠do not apply to wounds, broken skin or irritated skin ⢠do not use with other ointments, creams, sprays, liniments or other nsaids ⢠do not apply to irritated skin or if excessive irritation develops ⢠do not bandage ⢠wash hands with soap & cool water after using ⢠do not expose trated area to direct sunlight, hear or warm/hot water stop use and ask a doctor if: condition worsens or if symptoms persist for more than 7 days, or clear up and reccur ⢠pregnant or breast-feeding: ask a health professional before use
When Using:
When using this product avoid contact with eyes or muccus membranes ⢠do not apply to wounds, broken skin or irritated skin ⢠do not use with other ointments, creams, sprays, liniments or other nsaids ⢠do not apply to irritated skin or if excessive irritation develops ⢠do not bandage ⢠wash hands with soap & cool water after using ⢠do not expose trated area to direct sunlight, hear or warm/hot water
Dosage and Administration:
Directions: adults/children 12 years of age and older: massage into affected area no more than 4 times daily. ⢠children under 12 years of age: consult a physician. â¢if first time user, test in a small area.
Stop Use:
Stop use and ask a doctor if: condition worsens or if symptoms persist for more than 7 days, or clear up and reccur ⢠pregnant or breast-feeding: ask a health professional before use
Package Label Principal Display Panel:
Package labeling: label
Further Questions:
Questions or comments? info@performpainrelief.com 1-800-755-2584