Label: PROSTOFORCE (aralia quinquefolia, damiana, hydrocotyle asiatica, sabal serrulata, thuja occidentalis, pareira brava, clematis erecta, conium maculatum, juniperus virginiana, pulsatilla- vulgaris 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 18, 2020

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  • ACTIVE INGREDIENTS:

    Aralia Quinquefolia 3X, Damiana 3X, Hydrocotyle Asiatica 3X, Sabal Serrulata 3X, Thuja Occidentalis 3X, Pareira Brava 8X, Clematis Erecta 12X, Conium Maculatum 12X, Juniperus Virginiana 12X, Pulsatilla (Vulgaris) 12X.

  • INDICATIONS:

    For temporary relief of pain down thighs during efforts to urinate; great straining and constant urging when urinating.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care 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 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:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of pain down thighs during efforts to urinate; great straining and constant urging when urinating.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    PROSTOFORCE

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Prostoforce

  • INGREDIENTS AND APPEARANCE
    PROSTOFORCE 
    aralia quinquefolia, damiana, hydrocotyle asiatica, sabal serrulata, thuja occidentalis, pareira brava, clematis erecta, conium maculatum, juniperus virginiana, pulsatilla (vulgaris) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0560
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG3 [hp_X]  in 1 mL
    TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG3 [hp_X]  in 1 mL
    CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) (CENTELLA ASIATICA WHOLE - UNII:7M867G6T1U) CENTELLA ASIATICA WHOLE3 [hp_X]  in 1 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO3 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG3 [hp_X]  in 1 mL
    CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z) CHONDRODENDRON TOMENTOSUM ROOT8 [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
    JUNIPERUS VIRGINIANA TWIG (UNII: 532BCG080L) (JUNIPERUS VIRGINIANA TWIG - UNII:532BCG080L) JUNIPERUS VIRGINIANA TWIG12 [hp_X]  in 1 mL
    PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (PULSATILLA VULGARIS WHOLE - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0560-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/18/2020
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0560) , api manufacture(43857-0560) , label(43857-0560) , pack(43857-0560)
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