Label: PROSTATONE (echinacea (angustifolia), sabal serrulata, sarsaparilla (smilax regelii), solidago virgaurea, zincum sulphuricum, phytolacca decandra, hydrastis canadensis, orchitinum (suis), prostate (suis), clematis erecta, phosphoricum acidum, pulsatilla- vulgaris liquid

  • NDC Code(s): 43857-0492-1
  • Packager: BioActive Nutritional, Inc.
  • 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 August 29, 2018

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  • ACTIVE INGREDIENTS:

    Echinacea (Angustifolia) 3X, Sabal Serrulata 3X, Sarsaparilla (Smilax Regelii) 3X, Solidago Virgaurea 3X, Zincum Sulphuricum 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 5X, Orchitinum (Suis) 8X, Prostate (Suis) 8X, Clematis Erecta 12X, Phosphoricum Acidum 12X, Pulsatilla (Vulgaris) 12X.

  • INDICATIONS:

    For temporary relief of pain in the scrotum, testicles tender & swollen.

  • 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 in the scrotum, testicles tender & swollen.

  • 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

    PROSTATONE

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Prostatone

  • INGREDIENTS AND APPEARANCE
    PROSTATONE 
    echinacea (angustifolia), sabal serrulata, sarsaparilla (smilax regelii), solidago virgaurea, zincum sulphuricum, phytolacca decandra, hydrastis canadensis, orchitinum (suis), prostate (suis), clematis erecta, phosphoricum acidum, pulsatilla (vulgaris) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0492
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO3 [hp_X]  in 1 mL
    SARSAPARILLA (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SARSAPARILLA3 [hp_X]  in 1 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]  in 1 mL
    ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT4 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]  in 1 mL
    SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28) SUS SCROFA TESTICLE8 [hp_X]  in 1 mL
    SUS SCROFA PROSTATE (UNII: O6UD3347K2) (SUS SCROFA PROSTATE - UNII:O6UD3347K2) SUS SCROFA PROSTATE8 [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
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0492-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/29/2018
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0492) , api manufacture(43857-0492) , label(43857-0492) , pack(43857-0492)
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