Dr Joe Lab Pms Menstrual Pain Relief Oil
Menthol, Methyl Salicylate
Dr Joe Lab, Inc.
Human Otc Drug
NDC 82331-111Dr Joe Lab Pms Menstrual Pain Relief Oil also known as Menthol, Methyl Salicylate is a human otc drug labeled by 'Dr Joe Lab, Inc.'. National Drug Code (NDC) number for Dr Joe Lab Pms Menstrual Pain Relief Oil is 82331-111. This drug is available in dosage form of Oil. The names of the active, medicinal ingredients in Dr Joe Lab Pms Menstrual Pain Relief Oil drug includes Menthol, Unspecified Form - 1.4 g/100mL Methyl Salicylate - 10 g/100mL . The currest status of Dr Joe Lab Pms Menstrual Pain Relief Oil drug is Active.
Drug Information:
| Drug NDC: | 82331-111 |
| 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: | Dr Joe Lab Pms Menstrual Pain Relief Oil |
| 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, Methyl Salicylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dr Joe Lab, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Oil |
| 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 - 1.4 g/100mL
METHYL SALICYLATE - 10 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: | 07 Apr, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Jun, 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: | Dr Joe Lab, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2599520
|
| 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
LAV5U5022Y
|
| 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 |
|---|
| 82331-111-04 | 1 BOTTLE in 1 CARTON (82331-111-04) / 118 mL in 1 BOTTLE | 07 Apr, 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:
Dr joe lab pms menstrual pain relief oil menthol, methyl salicylate menthol, unspecified form menthol methyl salicylate salicylic acid .alpha.-tocopherol butylated hydroxytoluene isopropyl myristate eucalyptus oil
Indications and Usage:
Uses temporarily relieves minor pain associated with menstrual cramps.
Warnings:
Warnings for external use only when using this product ⢠use only as directed ⢠avoid contact with eyes or mucous membranes ⢠do not apply to wounds or damaged skin stop use and ask a doctor if ⢠condition worsens ⢠symptoms persist for more than 7 days or clear up and occur again within a few days ⢠redness is present ⢠irritation develops. allergy alert do not use if you are allergic to salicylates (including aspirin) without consulting a physician. if pregnant or breast-feeding, ask a health professional before use. keep out of the reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions adults and children over 12 years of age: ⢠apply to affected area ⢠massage into painful area until thoroughly absorbed into skin ⢠repeat as necessary, but no more than 4 times daily.
Package Label Principal Display Panel:
Packaging dr.joe-111
Further Questions:
Questions or comments? 1-855-349-7735 or visit www.drjoelab.com to report serious adverse events associated with use of the product.