Label: BIO SCLERANTHUS- scleranthus annuus, flos liquid

  • NDC Code(s): 43857-0307-1
  • 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 June 1, 2016

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  • ACTIVE INGREDIENTS:

    Scleranthus Annus, Flos 6X, 30C, 200C.

  • INDICATIONS:

    For temporary relief of uncertainty, indecision, vacillation; fluctuating moods.  

  • 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 uncertainty, indecision, vacillation; fluctuating moods.  

  • 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

    BIO SCLERANTHUS

    6X, 30C, 200C

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Bio Scleranthus 6X, 30C, 200C

  • INGREDIENTS AND APPEARANCE
    BIO SCLERANTHUS 
    scleranthus annuus, flos liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0307
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SCLERANTHUS ANNUUS FLOWERING TOP (UNII: CC4B5WU2XX) (SCLERANTHUS ANNUUS FLOWERING TOP - UNII:CC4B5WU2XX) SCLERANTHUS ANNUUS FLOWERING TOP6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0307-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/03/2014
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0307) , api manufacture(43857-0307) , label(43857-0307) , pack(43857-0307)
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