Tuvivex10
Menthol, Unspecified Form
Tuvive Therapeutics
Human Otc Drug
NDC 73501-501Tuvivex10 also known as Menthol, Unspecified Form is a human otc drug labeled by 'Tuvive Therapeutics'. National Drug Code (NDC) number for Tuvivex10 is 73501-501. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Tuvivex10 drug includes Menthol, Unspecified Form - 40 mg/mL . The currest status of Tuvivex10 drug is Active.
Drug Information:
| Drug NDC: | 73501-501 |
| 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: | Tuvivex10 |
| 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, Unspecified Form |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Tuvive Therapeutics |
| 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: | MENTHOL, UNSPECIFIED FORM - 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: | 10 Feb, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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. |
| 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: | Tuvive Therapeutics
|
| 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: | 0735010501109
|
| UPC stands for Universal Product Code. |
| UNII: | 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 |
|---|
| 73501-501-10 | 100 mL in 1 BOTTLE, PUMP (73501-501-10) | 10 Feb, 2020 | 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:
Tuvivex10 menthol, unspecified form menthol, unspecified form menthol, unspecified form water emu oil alcohol stearic acid glycerin glyceryl monostearate medium-chain triglycerides cetyl alcohol caprylyl glycol phenoxyethanol hexylene glycol squalane stearyl alcohol cannabidiol sodium hydroxide aloe vera leaf indian frankincense arnica montana flower
Indications and Usage:
Uses aid for temporary local relief of minor pain in muscles or joints.
Warnings:
Warnings for external use only. avoid contact with eyes. do not apply to wounds or damaged skin. if symptoms persist for more than seven days, discontinue use and consult a physician. if pregnant or breastfeeding ask a health professional before use. keep out of reach of children. if swallowed, get medical help right away.
Dosage and Administration:
Directions adults and children two years of age or older: apply to affected area not more than three to four times daily. children under two years of age, consult a physician.
Package Label Principal Display Panel:
Principal display panel - 100 ml bottle label tuvīve therapeutics 73501-501-10 tuvīvex⢠10 menthol 4% with premium cbd and emu oil topical pain cream cbd 1000mg per bottle 3.4 fl. oz (100 ml) principal display panel - 100 ml bottle label
Further Questions:
To report a serious adverse event or to obtain product information, contact company number at 1-844-720-7251