Label: PROSTATE STRENGTHENER- baryta carbonica, chimaphila umbellata, clematis erecta, conium maculatum, digitalis purpurea, phosphoricum acidum, sabal serrulata, selenium metallicum, staphysagria, thuja occidentalis, 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 March 31, 2014

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  • ACTIVE INGREDIENT

    HPUS active ingredients: Baryta carbonica, Chimaphila umbellata, Clematis erecta, Conium maculatum, Digitalis purpurea, Phosphoricum acidum, Sabal serrulata, Selenium metallicum, Staphysagria, Thuja occidentalis, Zincum metallicum. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.​

  • PURPOSE

    Uses​ for temporary relief of prostate symptoms: scanty urination, dribbling, burning and irritation, premature impotence.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Bio-Energetically Enhanced™ pure water base, Citric acid and Potassium sorbate.

  • WARNINGS

    Warning

    • Stop use and ask a doctor. If symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults 12 and up: 3 sprays 3 times per day.
    • Use additonally as needed, up to 6 times per day.
  • OTHER SAFETY INFORMATION

    Other Information: Tamper resistant for your protection. Use only if safety seal is intact.

  • INDICATIONS & USAGE

    Uses for temporary relief of prostate symptoms:

    • scanty urination
    • dribbling
    • burning and irritation
    • premature impotence
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PROSTATE STRENGTHENER 
    baryta carbonica, chimaphila umbellata, clematis erecta, conium maculatum, digitalis purpurea, phosphoricum acidum, sabal serrulata, selenium metallicum, staphysagria, thuja occidentalis, zincum metallicum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE10 [hp_X]  in 59 mL
    CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA10 [hp_X]  in 59 mL
    CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F) CLEMATIS RECTA FLOWERING TOP10 [hp_X]  in 59 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP10 [hp_X]  in 59 mL
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS10 [hp_X]  in 59 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID10 [hp_X]  in 59 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO10 [hp_X]  in 59 mL
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM10 [hp_X]  in 59 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED10 [hp_X]  in 59 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG10 [hp_X]  in 59 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0011-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/31/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0011)
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