Pain Relief Audacious Wreck Relief
Menthol 4%
Australis Capital (nevada) Inc.
Human Otc Drug
NDC 82212-003Pain Relief Audacious Wreck Relief also known as Menthol 4% is a human otc drug labeled by 'Australis Capital (nevada) Inc.'. National Drug Code (NDC) number for Pain Relief Audacious Wreck Relief is 82212-003. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Pain Relief Audacious Wreck Relief drug includes Menthol - 4 g/100mL . The currest status of Pain Relief Audacious Wreck Relief drug is Active.
Drug Information:
| Drug NDC: | 82212-003 |
| 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: | Pain Relief Audacious Wreck Relief |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Pain Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Audacious Wreck Relief |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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 4% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Australis Capital (nevada) 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 - 4 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: | 08 Nov, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 02 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: | Australis Capital (Nevada) 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. |
| UPC: | 0382212000000
|
| 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 |
|---|
| 82212-003-02 | 89 mL in 1 BOTTLE (82212-003-02) | 08 Nov, 2021 | 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:
Product Elements:
Pain relief audacious wreck relief menthol 4% aloe arctium lappa root arnica montana flower frankincense calendula officinalis flower green tea leaf camphor (synthetic) carbomer 940 hemp glycerin ilex paraguariensis leaf isopropyl alcohol isopropyl myristate melissa officinalis leaf silicon dioxide .alpha.-tocopherol acetate trolamine water menthol menthol
Indications and Usage:
Uses: temporary relief from minor aches pains of muscles and joints associated with simple backache, strains and sprains
Warnings:
Warnings for external use only when using this product ⢠use only as directed ⢠do not bandage tightly or use with a heating pad ⢠avoid contact with eyes and mucous membranes ⢠do not apply to wounds or damaged, broken or irritated skin ⢠a transient burning sensation may occur upon application but generally disappears in several days ⢠i f severe burning sensation occurs, discontinue use immediately ⢠do not expose the area treated with product to heat or direct sunlight. stop use and ask doctor if ⢠condition worsens ⢠blistering or burning occurs ⢠pain or swelling occures ⢠symptoms persist for more than 7 days or clear up and occur again within a few days flammable ⢠keep away from fire or flame if pregnant or breast-feeding, ask a health professional before use.
Dosage and Administration:
Direction ⢠adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily ⢠children under 2 years old: consult a doctor
Package Label Principal Display Panel:
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