PROSTATONE (hydrangea arborescens, sabal serrulata, chimaphila umbellata, clematis erecta, conium maculatum, pareira brava, pulsatilla- pratensis, thuja occidentalis, triticum occidentalis, triticum repens, staphysagria, zincum metallicum liquid

Prostatone by

Drug Labeling and Warnings

Prostatone by is a Homeopathic medication manufactured, distributed, or labeled by Energique, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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.

INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol.

QUESTIONS:

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

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

PROSTATONE

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

PROSTATONE 
hydrangea arborescens, sabal serrulata, chimaphila umbellata, clematis erecta, conium maculatum, pareira brava, pulsatilla (pratensis), thuja occidentalis, triticum occidentalis, triticum repens, staphysagria, zincum metallicum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44911-0494
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDRANGEA ARBORESCENS ROOT (UNII: SFK828Q2DE) (HYDRANGEA ARBORESCENS ROOT - UNII:SFK828Q2DE)	HYDRANGEA ARBORESCENS ROOT	3 [hp_X]  in 1 mL
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	3 [hp_X]  in 1 mL
CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J)	CHIMAPHILA UMBELLATA	4 [hp_X]  in 1 mL
CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F)	CLEMATIS RECTA FLOWERING TOP	12 [hp_X]  in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	12 [hp_X]  in 1 mL
CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z)	CHONDRODENDRON TOMENTOSUM ROOT	12 [hp_X]  in 1 mL
PULSATILLA PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI)	PULSATILLA PRATENSIS	12 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	12 [hp_X]  in 1 mL
ELYMUS REPENS ROOT (UNII: 3IXW0F6P8W) (ELYMUS REPENS ROOT - UNII:3IXW0F6P8W)	ELYMUS REPENS ROOT	12 [hp_X]  in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	12 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44911-0494-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/11/2019

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(44911-0494) , api manufacture(44911-0494) , label(44911-0494) , pack(44911-0494)