Mencaps
Capsaicin And Menthol
Alexso Inc
Human Otc Drug
NDC 50488-1701Mencaps also known as Capsaicin And Menthol is a human otc drug labeled by 'Alexso Inc'. National Drug Code (NDC) number for Mencaps is 50488-1701. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Mencaps drug includes Capsaicin - .0225 g/1 Menthol, Unspecified Form - 4.5 g/1 . The currest status of Mencaps drug is Active.
Drug Information:
| Drug NDC: | 50488-1701 |
| 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: | Mencaps |
| 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 And Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alexso Inc |
| 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 - .0225 g/1
MENTHOL, UNSPECIFIED FORM - 4.5 g/1
|
| 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: | 01 Jul, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | Alexso Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1658663
|
| 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
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 |
|---|
| 50488-1701-1 | 3 POUCH in 1 BOX (50488-1701-1) / 5 PATCH in 1 POUCH | 01 Jul, 2015 | 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
Purpose topical anesthetic
Product Elements:
Mencaps capsaicin and menthol capsaicin capsaicin menthol, unspecified form menthol, unspecified form water glycerin sodium polyacrylate (8000 mw) polysorbate 80 lemon peel aloe vera leaf edetate disodium diazolidinyl urea methylparaben iodopropynyl butylcarbamate propylparaben
Indications and Usage:
Uses: for temporary relief of minor aches & pains of muscles & joints associated with arthritis, simple backache, strains, bruises, and sprains.
Indications and usage: mencaps patch ® is a formulation used to assist patients for the temporary relief of minor aches & pains of muscles & joints associated with arthritis, simple backache, strains, bruises, and sprains. peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, may also be symptomatically improved using this patch if recommended by the healthcare team. other uses may be considered if deemed clinically relevant.
Warnings:
Warnings: ⢠for external use only. use only as directed or by a health professional. ⢠do not use: on wounds, cuts, damaged or infected skin. - on eyes, mouth, genitals, or any other mucus membranes. ⢠stop and consult your physician if pregnant or if pain worsens ⢠allergy alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use.
Warnings and Cautions:
Warnings: 1. do not use: ⢠on wounds, cuts, damaged or infected skin ⢠on eyes, mouth, genitals, or other mucous membranes 2. consult physician for children under 12 years of age 3. stop and consult your prescriber if pain worsens 4. discontinue use at least 1 hours before a bath or shower and do not use immediately after a bath or shower call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: ⢠shortness of breath ⢠swelling or numbness of the tongue or throat ⢠severe headache or vomiting ⢠dizziness or faintness ⢠changes in vision or speech this is not a complete list of the possible side effects. for more information, talk with your doctor or pharmacist. you may report side effects to fda at 1-800-fda-1088 or www.fda.gov/medwatch .
Do Not Use:
Warnings: ⢠for external use only. use only as directed or by a health professional. ⢠do not use: on wounds, cuts, damaged or infected skin. - on eyes, mouth, genitals, or any other mucus membranes. ⢠stop and consult your physician if pregnant or if pain worsens ⢠allergy alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use.
Dosage and Administration:
Directions: adults and children 12 years and over: 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. instructions for use: ⢠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. ⢠discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower. ⢠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.
Contraindications:
Contraindications: known hypersensitivity to menthol, capsaicin, or any of the inactive ingredients listed above. warnings: 1. do not use on wounds, cuts, damaged or infected skin 2. do not use on eyes, mouth, genitals, or any other mucous membranes 3. keep out of reach of children
Adverse Reactions:
Adverse reactions: the most common adverse reactions are application site reactions, including dermatitis, itching or scaling. these tend to be dose-limiting and diminish with time. serious adverse experiences following the administration of mencaps patch ® are similar in nature to those observed in other amide anesthetic-containing agents. these adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. serious adverse experiences are generally systemic in nature.
Overdosage:
Overdosage: there have been no reports of over-dosage with mencaps patch ® . signs of overdosage would include vomiting, drowsiness, coma, respiratory depression, and seizures. in the case of an overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.
Description:
Description: mencaps patch ® is an otc topical patch containing 15 articulated mencaps patches (5 per re-sealable pouch x 3 pouches). capsaicin is present in a 0.0225% concentration (w/w). it is chemically designated as ( e )- n -[(4-hydroxy-3-methoxyphenyl) methyl]-8- methylnon-6-enamide and has an empirical formula of c 18 h 27 no 3 . the molecular weight of capsaicin is 305.41 g/mol. menthol is present in a 4.5% concentration (w/w). the chemical name is (1 r ,2 s ,5 r )-2- isopropyl-5-methylcyclohexanol. the empirical formula for menthol is c 10 h 20 o with a molecular weight of 156.27 g/mol. the structural formulas are: box label chemical structure
Package Label Principal Display Panel:
Package/label principal display panel ndc 50488-1701-1 mencaps patch qty: 15 patches (5 per resealable pouch) x 3 box label carton label
Further Questions:
Questions or comments call 888.495.6078