NDC 44911-0494 Prostatone

Hydrangea Arborescens, Sabal Serrulata, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Pareira Brava, Pulsatilla (pratensis), Thuja Occidentalis, Triticum Occidentalis, Triticum Repens, Staphysagria, Zincum Metallicum

NDC Product Code 44911-0494

NDC Code: 44911-0494

Proprietary Name: Prostatone What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydrangea Arborescens, Sabal Serrulata, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Pareira Brava, Pulsatilla (pratensis), Thuja Occidentalis, Triticum Occidentalis, Triticum Repens, Staphysagria, Zincum Metallicum What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 44911 - Energique, Inc.
    • 44911-0494 - Prostatone

NDC 44911-0494-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Prostatone with NDC 44911-0494 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Prostatone is hydrangea arborescens, sabal serrulata, chimaphila umbellata, clematis erecta, conium maculatum, pareira brava, pulsatilla (pratensis), thuja occidentalis, triticum occidentalis, triticum repens, staphysagria, zincum metallicum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Energique, 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.

Prostatone 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.

  • HYDRANGEA ARBORESCENS ROOT 3 [hp_X]/mL
  • SAW PALMETTO 3 [hp_X]/mL
  • CHIMAPHILA UMBELLATA 4 [hp_X]/mL
  • CLEMATIS RECTA FLOWERING TOP 12 [hp_X]/mL
  • CONIUM MACULATUM FLOWERING TOP 12 [hp_X]/mL
  • CHONDRODENDRON TOMENTOSUM ROOT 12 [hp_X]/mL
  • PULSATILLA PRATENSIS 12 [hp_X]/mL
  • THUJA OCCIDENTALIS LEAFY TWIG 12 [hp_X]/mL
  • ELYMUS REPENS ROOT 12 [hp_X]/mL
  • DELPHINIUM STAPHISAGRIA SEED 12 [hp_X]/mL
  • ZINC 12 [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.

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

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: Energique, Inc.
Labeler Code: 44911
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: 04-11-2019 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: 12-31-2020 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.

Prostatone Product Label Images

Prostatone 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

Active Ingredients:

(in each drop): 12.46% of Clematis Erecta 12X, Conium Maculatum 12X, Pareira Brava 12X, Pulsatilla (Pratensis) 12X, Staphysagria 12X, Thuja Occidentalis 12X, Triticum Repens 12X, Zincum Metallicum 12X; 0.10% of Chimaphila Umbellata 4X, Hydrangea Arborescens 3X, Sabal Serrulata 3X.

Indications:

May temporarily relieve pain down thighs during efforts to urinate, great straining and constant urging when urinating.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

May temporarily relieve pain down thighs during efforts to urinate, great straining and constant urging when urinating.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

If pregnant or breastfeeding, ask a health professional before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.Do not use if tamper evident seal is broken or missing.Store in a cool, dry place.

Keep Out Of Reach Of Children:

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

Directions:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Questions:

Dist. by Energique, Inc.201 Apple Blvd.Woodbine, IA 51579   800.868.8078

Package Label Display:

ENERGIQUESINCE 1987HOMEOPATHIC REMEDYPROSTATONE1 fl. oz. (30 ml)

* Please review the disclaimer below.

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