Male-pros

Prostrate Booster


Vitality Works, Inc.
Human Otc Drug
NDC 64616-098
Male-pros also known as Prostrate Booster is a human otc drug labeled by 'Vitality Works, Inc.'. National Drug Code (NDC) number for Male-pros is 64616-098. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Male-pros drug includes Actaea Spicata Root - 10 [hp_X]/mL Antimony Trisulfide - 9 [hp_C]/mL Arnica Montana - 7 [hp_X]/mL Chelidonium Majus - 6 [hp_X]/mL Clematis Recta Flowering Top - 15 [hp_X]/mL Cypripedium Parviflorum Var. Pubescens Root - 14 [hp_X]/mL Hexaplex Trunculus Hypobranchial Gland Juice - 20 [hp_X]/mL Kerosene - 10 [hp_X]/mL Ledum Palustre Twig - 7 [hp_X]/mL Mercuric Cyanide - 14 [hp_X]/mL and more. The currest status of Male-pros drug is Active.

Drug Information:

Drug NDC: 64616-098
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: Male-pros
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: Prostrate Booster
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Vitality Works, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Liquid
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:ACTAEA SPICATA ROOT - 10 [hp_X]/mL
ANTIMONY TRISULFIDE - 9 [hp_C]/mL
ARNICA MONTANA - 7 [hp_X]/mL
CHELIDONIUM MAJUS - 6 [hp_X]/mL
CLEMATIS RECTA FLOWERING TOP - 15 [hp_X]/mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - 14 [hp_X]/mL
HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE - 20 [hp_X]/mL
KEROSENE - 10 [hp_X]/mL
LEDUM PALUSTRE TWIG - 7 [hp_X]/mL
MERCURIC CYANIDE - 14 [hp_X]/mL
MERCURIUS SOLUBILIS - 12 [hp_X]/mL
OCIMUM AMERICANUM LEAF - 15 [hp_X]/mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM - 70 [hp_X]/mL
SILVER NITRATE - 15 [hp_X]/mL
VERATRUM ALBUM ROOT - 6 [hp_X]/mL
ZINC OXIDE - 6 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
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 HOMEOPATHIC
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 Apr, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jan, 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:Vitality Works, 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.
UNII:3FU86L9OS0
F79059A38U
O80TY208ZW
7E889U5RNN
396421SP9F
21Y9GZ1LZA
IQV54TN60Y
1C89KKC04E
877L01IZ0P
RWG7BD1032
324Y4038G2
4EX119B76E
36XQ854NWW
95IT3W8JZE
QNS6W5US1Z
SOI2LOH54Z
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:Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
64616-098-0259 mL in 1 BOTTLE, DROPPER (64616-098-02)08 Apr, 2013N/ANo
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:

Male-pros aids in prostrate health.

Product Elements:

Male-pros prostrate booster alcohol water antimony trisulfide antimony trisulfide silver nitrate silver cation arnica montana arnica montana chelidonium majus chelidonium majus clematis recta flowering top clematis recta flowering top cypripedium parviflorum var. pubescens root cypripedium parviflorum var. pubescens root pseudognaphalium obtusifolium pseudognaphalium obtusifolium ledum palustre twig ledum palustre twig mercuric cyanide mercuric cyanide mercurius solubilis mercurius solubilis hexaplex trunculus hypobranchial gland juice hexaplex trunculus hypobranchial gland juice ocimum americanum leaf ocimum americanum leaf kerosene kerosene veratrum album root veratrum album root zinc oxide zinc cation actaea spicata root actaea spicata root

Indications and Usage:

Male-pros for the temporary relief of male sexual dysfunction and low back pain.

Warnings:

Male-pros use only under the direction of a health care professional. do not use if tamper evident seal is broken or missing.

Dosage and Administration:

Male-pros orally 25 drops, 2 times per day or as indicated by a physician. children 12 and under use one half the adult dosage.

Package Label Principal Display Panel:

Male-pros label


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.