Joint And Muscle Pain Relief
Menthol
Allure Labs
Human Otc Drug
NDC 62742-4219Joint And Muscle Pain Relief also known as Menthol is a human otc drug labeled by 'Allure Labs'. National Drug Code (NDC) number for Joint And Muscle Pain Relief is 62742-4219. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Joint And Muscle Pain Relief drug includes Menthol - 1.5 g/100g . The currest status of Joint And Muscle Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 62742-4219 |
| 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: | Joint And Muscle 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Allure Labs |
| 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 - 1.5 g/100g
|
| 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 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: | 08 Sep, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | M015 |
| 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: | Allure Labs
|
| 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 |
|---|
| 62742-4219-2 | 1 TUBE in 1 CARTON (62742-4219-2) / 57 g in 1 TUBE (62742-4219-1) | 08 Sep, 2022 | 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:
Joint and muscle pain relief menthol pyridoxine hydrochloride citric acid monohydrate sodium benzoate diacetylated monoglycerides glycerin cannabis sativa seed oil arnica montana flower cetostearyl alcohol polyoxyl 20 cetostearyl ether peg-100 stearate shea butter cetyl esters wax glyceryl monostearate menthol menthol water peppermint oil phenoxyethanol potassium sorbate tocopherol sunflower oil .beta.-sitosterol dimethyl sulfone glucosamine hydrochloride ethylhexylglycerin ammonium acryloyldimethyltaurate/vp copolymer aloe vera leaf diethylene glycol monoethyl ether dimethicone glycyrrhizinate dipotassium squalene linalool, (+/-)- limonene, (+)- methyl gluceth-20 tea tree oil frankincense oil
Indications and Usage:
Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains
Warnings:
Warnings for external use only
Do Not Use:
Warnings for external use only
When Using:
When using this product avoid contact with eyes do not bandage tightly
Dosage and Administration:
Directions adults and children 2 years of age and olden apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor
Stop Use:
Stop use and ask a doctor if condition worsens irritation occurs symptoms persist for more than 7 days or clear up and occur again within a few days
Package Label Principal Display Panel:
Joint & muscle pain relief