Label: GUNA-PROSTATE- aldesleukin - barium carbonate - chaste tree - chimaphila umbellata - clematis vitalba - conium maculatum flowering top - delphinium staphisagria seed - digitalis - ferric picrate - human interleukin-10 (nonglycosylated) - interferon gamma-1b - melatonin - saw palmetto - selenium - sus scrofa prostate - thuja occidentalis twig - transforming growth factor beta-1 - zinc - solution/ drops

  • 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 December 21, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS/PURPOSE

    AGNUS CASTUS        6X    INCONTINENCE
    BARYTA CARBONICA    12X 30X    PAINFUL URINATION
    CHIMAPHILA UMBELLATA    6X    DETOXIFICATION
    CLEMATIS ERECTA        3X    ANTIOXIDANT
    CONIUM MACULATUM    12X 30X    ANTIOXIDANT
    DIGITALIS PURPUREA    12X 30X    RELIEVES URINARY IRRITATION
    FERRUM PICRINICUM    12X 30X    SUDDEN URGE TO URINATE
    INTERFERON GAMMA    4C    ANTIOXIDANT
    INTERLEUKIN 10        4C    PAINFUL URINATION
    INTERLEUKIN 2        4C    PAINFUL URINATION
    MELATONIN        4C    HORMONAL REGULATION
    PROSTATE        200X    PAINFUL URINATION
    SABAL SERRULATA        3X    PAINFUL URINATION
    SELENIUM METALLICUM    12X 30X    SLOWED START OF URINATION
    STAPHYSAGRIA        12X 30X    PAINFUL URINATION
    TGF BETA        4C    PAINFUL URINATION
    THUJA OCCIDENTALIS    12X 30X    SLOWED START OF URINATION
    ZINCUM METALLICUM    3X    SLOWED START OF URINATION

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  • USES

    Temporary relief of symptoms such as:

    • Urinary disconfort, hesitancy, frequency
    • Slow or painful urination
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  • WARNINGS

    • Stop use and ask doctor if symptoms persist more than 5 days or worsen.
    • If pregnant or breast-feeding 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.
    • Contains ethyl alcohol 30%


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  • PREGNANCY

    If pregnant or breast-feeding ask a doctor before use

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  • WARNINGS

    Keep out of reach of children

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  • DIRECTIONS

    Directions:

    Take 15 minutes before meals

    Adults: 20 drops in a little water, 2 times per day


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  • QUESTIONS

    Questions?: info@gunainc.com, tel. (484) 223-3500

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  • INACTIVE INGREDIENT

    Inactive ingredient: Ethyl alcohol 30%.

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  • INDICATIONS & USAGE

    • Take 15 minutes before meals.
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  • INDICATIONS & USAGE

    • indications and usage section
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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    GUNA-PROSTATE 
    aldesleukin - barium carbonate - chaste tree - chimaphila umbellata - clematis vitalba - conium maculatum flowering top - delphinium staphisagria seed - digitalis - ferric picrate - human interleukin-10 (nonglycosylated) - interferon gamma-1b - melatonin - saw palmetto - selenium - sus scrofa prostate - thuja occidentalis twig - transforming growth factor beta-1 - zinc - solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:17089-346
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERRIC PICRATE (UNII: KZM8ZRY36A) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION 30 [hp_X]  in 30 mL
    CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE 6 [hp_X]  in 30 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE 30 [hp_X]  in 30 mL
    CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA 6 [hp_X]  in 30 mL
    CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F) CLEMATIS RECTA FLOWERING TOP 3 [hp_X]  in 30 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP 30 [hp_X]  in 30 mL
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS 30 [hp_X]  in 30 mL
    INTERFERON GAMMA-1B (UNII: 21K6M2I7AG) (INTERFERON GAMMA-1B - UNII:21K6M2I7AG) INTERFERON GAMMA-1B 4 [hp_C]  in 30 mL
    INTERLEUKIN-10 (UNII: 9SC4O216V9) (INTERLEUKIN-10 - UNII:9SC4O216V9) INTERLEUKIN-10 4 [hp_C]  in 30 mL
    ALDESLEUKIN (UNII: M89N0Q7EQR) (ALDESLEUKIN - UNII:M89N0Q7EQR) ALDESLEUKIN 4 [hp_C]  in 30 mL
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN 4 [hp_C]  in 30 mL
    SUS SCROFA PROSTATE (UNII: O6UD3347K2) (SUS SCROFA PROSTATE - UNII:O6UD3347K2) SUS SCROFA PROSTATE 200 [hp_X]  in 30 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO 3 [hp_X]  in 30 mL
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 30 [hp_X]  in 30 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 30 [hp_X]  in 30 mL
    TRANSFORMING GROWTH FACTOR BETA-1 (UNII: T7D25J14LT) (TRANSFORMING GROWTH FACTOR BETA-1 - UNII:T7D25J14LT) TRANSFORMING GROWTH FACTOR BETA-1 4 [hp_C]  in 30 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_X]  in 30 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 3 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17089-346-18 1 in 1 BOX 12/21/2018
    1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/01/2017
    Labeler - Guna spa (430538264)
    Establishment
    Name Address ID/FEI Business Operations
    Guna spa 338587646 manufacture(17089-346)
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