Label: 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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated May 25, 2021

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  • 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)

    Prostatone

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0494
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDRANGEA ARBORESCENS ROOT (UNII: SFK828Q2DE) (HYDRANGEA ARBORESCENS ROOT - UNII:SFK828Q2DE) HYDRANGEA ARBORESCENS ROOT3 [hp_X]  in 1 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO3 [hp_X]  in 1 mL
    CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA4 [hp_X]  in 1 mL
    CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F) CLEMATIS RECTA FLOWERING TOP12 [hp_X]  in 1 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP12 [hp_X]  in 1 mL
    CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z) CHONDRODENDRON TOMENTOSUM ROOT12 [hp_X]  in 1 mL
    PULSATILLA PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS12 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG12 [hp_X]  in 1 mL
    ELYMUS REPENS ROOT (UNII: 3IXW0F6P8W) (ELYMUS REPENS ROOT - UNII:3IXW0F6P8W) ELYMUS REPENS ROOT12 [hp_X]  in 1 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED12 [hp_X]  in 1 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0494-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/11/2019
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0494) , api manufacture(44911-0494) , label(44911-0494) , pack(44911-0494)
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