Trivita Qpr
Menthol, Unspecified Form
Trivita, Inc.
Human Otc Drug
NDC 76571-313Trivita Qpr also known as Menthol, Unspecified Form is a human otc drug labeled by 'Trivita, Inc.'. National Drug Code (NDC) number for Trivita Qpr is 76571-313. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Trivita Qpr drug includes Menthol, Unspecified Form - 8.5 g/100mL . The currest status of Trivita Qpr drug is Active.
Drug Information:
| Drug NDC: | 76571-313 |
| 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: | Trivita Qpr |
| 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: | Trivita, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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 - 8.5 g/100mL
|
| 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 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 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: | TriVita, Inc.
|
| 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. |
| 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 |
|---|
| 76571-313-30 | 88 mL in 1 BOTTLE, WITH APPLICATOR (76571-313-30) | 01 Apr, 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:
Trivita qpr menthol, unspecified form menthol, unspecified form menthol, unspecified form aloe vera leaf arnica montana flower indian frankincense cannabis sativa seed oil carbomer homopolymer, unspecified type glucosamine sulfate glycerin ilex paraguariensis leaf isopropyl alcohol methylparaben dimethyl sulfone peppermint oil polysorbate 20 propylene glycol water trolamine
Indications and Usage:
Uses temporary relief from minor aches and pains from sore muscles and joints, backache, and arthritis.
Warnings:
Warnings for external use only. flammable: keep out of reach of children. contact a doctor before using if you have sensitive skin or are pregnant, breastfeeding or on any medications. if swallowed get medical help or call poison control center immediately. when using this product do not use with heating pad or on heated skin. do not bandage. do not apply to wounds or damaged skin. wash hands with cold water immediately after use, and do not touch eyes or mucous membranes. stop use and ask a doctor if redness or irritation occurs, if condition worsens, or if pain persists for more than 7 days or clears up, then reoccurs.
When Using:
When using this product do not use with heating pad or on heated skin. do not bandage. do not apply to wounds or damaged skin. wash hands with cold water immediately after use, and do not touch eyes or mucous membranes.
Dosage and Administration:
Directions use only as directed. do not use on children under 12 years of age. roll onto affected area no more than four times daily.
Stop Use:
Stop use and ask a doctor if redness or irritation occurs, if condition worsens, or if pain persists for more than 7 days or clears up, then reoccurs.
Package Label Principal Display Panel:
Principal display panel - 88 ml bottle label trivita qpr quick pain relief soothing menthol formula for fast-acting temporary relief of minor aches & pains ~{ easy roll-on applicator!}~ 150 mg cbd contains broad-spectrum thc-free hemp cbd 3fl ounces (88 ml) principal display panel - 88 ml bottle label