Label: BIO WATER VIOLET- hottonia palustris, flos liquid

  • NDC Code(s): 43857-0327-1
  • 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 May 7, 2019

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

  • ACTIVE INGREDIENTS:

    Hottonia Palustris, Flos 6X, 30C, 200C

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  • INDICATIONS:

    For temporary relief of feeling superiority in isolation, little emotional involvement; proud withdrawal; shyness.

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  • 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.

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  • 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.

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  • DIRECTIONS:

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

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  • INDICATIONS:

    For temporary relief of feeling superiority in isolation, little emotional involvement; proud withdrawal; shyness.

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  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

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  • QUESTIONS:

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

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  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    BIO WATER VIOLET

    6X, 30C, 200C

    HOMEOPATHIC

    1 FL OZ (30 ml)

    BIO WATER VIOLET

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  • INGREDIENTS AND APPEARANCE
    BIO WATER VIOLET 
    hottonia palustris, flos liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0327
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HOTTONIA PALUSTRIS FLOWER (UNII: Q954GT7P3G) (HOTTONIA PALUSTRIS FLOWER - UNII:Q954GT7P3G) HOTTONIA PALUSTRIS FLOWER 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43857-0327-1 30 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package 08/28/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 08/28/2014
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43857-0327) , api manufacture(43857-0327) , label(43857-0327) , pack(43857-0327)
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