NDC 64616-098 Male-pros

Prostrate Booster

NDC Product Code 64616-098

NDC Product Information

Male-pros with NDC 64616-098 is a a human over the counter drug product labeled by Vitality Works, Inc.. The generic name of Male-pros is prostrate booster. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Vitality Works, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Male-pros Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACTAEA SPICATA ROOT 10 [hp_X]/mL
  • ANTIMONY TRISULFIDE 9 [hp_C]/mL
  • SILVER NITRATE 15 [hp_X]/mL
  • ARNICA MONTANA 7 [hp_X]/mL
  • CHELIDONIUM MAJUS 6 [hp_X]/mL
  • CLEMATIS RECTA FLOWERING TOP 15 [hp_X]/mL
  • CYPRIPEDIUM PARVIFOLUM ROOT 14 [hp_X]/mL
  • PSEUDOGNAPHALIUM OBTUSIFOLIUM 70 [hp_X]/mL
  • LEDUM PALUSTRE TWIG 7 [hp_X]/mL
  • MERCURIC CYANIDE 14 [hp_X]/mL
  • MERCURIUS SOLUBILIS 12 [hp_X]/mL
  • HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE 20 [hp_X]/mL
  • OCIMUM AMERICANUM LEAF 15 [hp_X]/mL
  • KEROSENE 10 [hp_X]/mL
  • VERATRUM ALBUM ROOT 6 [hp_X]/mL
  • ZINC OXIDE 6 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Vitality Works, Inc.
Labeler Code: 64616
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 04-08-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Male-pros Product Label Images

Male-pros Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Male-Pros

Actaea Spicata 8X                                        Ledum Palustre 7XAntimonium Crudum 9C                               Mecurius Cyanatus 14XArgentum Nitricum 13X                                Mercurius Solubilis 12XArnica Montana 5X                                       Murex Purpurea 20XChelidonium Majus 6X                                 Ocimum Canum 15XClematis Erecta 6X, 15X                              Petroleum 10XCypripedium Pubescens 14X                       Veratrum Album 6XGnaphalium Polycephalum 70X                   Zincum Oxydatum 15X, 30X

Alcohol, Purified Water

Use only under the direction of a health care professional. Do not use if tamper evident seal is broken or missing.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

For the temporary relief of male sexual dysfunction and low back pain.

Orally 25 drops, 2 times per day or as indicated by a physician. Children 12 and under use one half the adult dosage.

Aids in prostrate health.

* Please review the disclaimer below.

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