Dakota Muscle Relief Roll-on
Menthol, Unspecified Form
Lashe Naturals, Llc
Human Otc Drug
NDC 71680-002Dakota Muscle Relief Roll-on also known as Menthol, Unspecified Form is a human otc drug labeled by 'Lashe Naturals, Llc'. National Drug Code (NDC) number for Dakota Muscle Relief Roll-on is 71680-002. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Dakota Muscle Relief Roll-on drug includes Menthol, Unspecified Form - 60 mg/mL . The currest status of Dakota Muscle Relief Roll-on drug is Active.
Drug Information:
| Drug NDC: | 71680-002 |
| 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: | Dakota Muscle Relief Roll-on |
| 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: | Lashe Naturals, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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 - 60 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: | 01 Nov, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | LaShe Naturals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 359752
|
| 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: | 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 |
|---|
| 71680-002-03 | 90 mL in 1 BOTTLE, WITH APPLICATOR (71680-002-03) | 19 Sep, 2017 | 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:
Dakota muscle relief roll-on menthol, unspecified form menthol, unspecified form menthol, unspecified form isopropyl alcohol water peppermint oil eucalyptus oil camphor oil, white clove oil emu oil xanthan gum
Indications and Usage:
Uses for the temporary relief of minor aches and pains associated with simple backache arthritis sprains joint pain bruises strains.
Warnings:
Warnings for external use only. avoid contact with eyes. if contact occurs, flush eyes with water immediately. flammable keep away from fire or flame. when using this product: use only as directed do not bandage or use with a heating pad do not apply to wounds or damaged skin discontinue use if irritation develops. stop use and ask your doctor if: condition worsens or if symptoms persist more than 7 days redness is present excessive irritation of the skin develops. if pregnant or breast feeding, ask a health professional before use. keep out of reach of children, if ingested get medical help immediately.
When Using:
When using this product: use only as directed do not bandage or use with a heating pad do not apply to wounds or damaged skin discontinue use if irritation develops.
Dosage and Administration:
Directions adults / children 12 years or older: shake well before use, test for skin sensitivity spray directly on affected area apply externally up to a maximum of 3 to 4 times a day do not rub.
Stop Use:
Stop use and ask your doctor if: condition worsens or if symptoms persist more than 7 days redness is present excessive irritation of the skin develops.
Package Label Principal Display Panel:
Principal display panel - 90 ml bottle label dakota muscle relief fast all natural pain relief temporary relief from: arthritis joint pain back pain sprains muscle aches cramps congestion insect bites fast acting ⢠not greasy pleasant scent roll-on muscle relief 3oz. (90ml.) principal display panel - 90 ml bottle label