Advanced Formula Progesto-life
Progesterone
Smoky Mountain Naturals, Llc - Dba Smnutrition
Human Otc Drug
NDC 82653-004Advanced Formula Progesto-life also known as Progesterone is a human otc drug labeled by 'Smoky Mountain Naturals, Llc - Dba Smnutrition'. National Drug Code (NDC) number for Advanced Formula Progesto-life is 82653-004. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Advanced Formula Progesto-life drug includes Progesterone - 16.9 mg/mL . The currest status of Advanced Formula Progesto-life drug is Active.
Drug Information:
| Drug NDC: | 82653-004 |
| 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: | Advanced Formula Progesto-life |
| 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: | Progesterone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Smoky Mountain Naturals, Llc - Dba Smnutrition |
| 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: | PROGESTERONE - 16.9 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: | UNAPPROVED DRUG OTHER |
| 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, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 2025 |
| 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. |
| 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: | Smoky Mountain Naturals, LLC - DBA SMNutrition
|
| 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: | 0850005458043
|
| UPC stands for Universal Product Code. |
| NUI: | M0017672
N0000175601
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 4G7DS2Q64Y
|
| 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. |
| Pharmacologic Class EPC: | Progesterone [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Progesterone [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Progesterone [CS]
Progesterone [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82653-004-01 | 150 mL in 1 BOTTLE, PUMP (82653-004-01) | 01 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 this is a topical cream that contains micronized, usp progesterone. when applied to the skin it may help support the bodyâs balance of hormones.
Product Elements:
Advanced formula progesto-life progesterone water medium-chain triglycerides shea butter cetyl alcohol stearic acid .alpha.-tocopherol acetate sodium hydroxymethylglycinate potassium sorbate progesterone progesterone
Indications and Usage:
Uses this is a topical cream that contains micronized, usp progesterone. when applied to the skin it may help support the bodyâs balance of hormones.
Warnings:
Warnings *these statements have not been evaluated by the food & drug administration. this product is not intended to diagnose, treat, cure, or prevent any disease. consult your healthcare provider before using this product especially if you are pregnant, nursing, intend to get pregnant, taking medication, or have a medical condition. this product does not treat, cure, or prevent menopause. if irritation occurs, discontinue use. for external use only. do not use around eye area. do not apply this cream internally. double check the ingredients list for known allergies before using this cream. keep out of the reach of children. do not use if safety seal is missing or broken. store in a cool, dry place.
Dosage and Administration:
Directions apply 1/4 tsp to inner wrists or abdomen twice per day 3 weeks of the month or as recommended by your physician.
Package Label Principal Display Panel:
Product label image description