Label: BIO HOLLY (ilex aquifolium- holly, flos liquid

  • NDC Code(s): 43857-0364-1
  • 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 6, 2023

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  • ACTIVE INGREDIENTS:

    Ilex Aquifolium (Holly), Flos 6X, 30C, 200C.

  • INDICATIONS:

    For temporary relief of hatred, envy, jealousy, and suspicion.

  • 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 a 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 hatred, envy, jealousy, and suspicion.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    BIOACTIVE NUTRITIONAL

    Melbourne, FL 32935

    For Nutritional Information Write:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

  • PACKAGE LABEL DISPLAY:

    BioActive Homeopathic

    BIO HOLLY 6X, 30C, 200C

    1 FL OZ (30 ML)

    BIO HOLLY 6X, 30C, 200C

  • INGREDIENTS AND APPEARANCE
    BIO HOLLY 
    ilex aquifolium (holly), flos liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0364
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ILEX AQUIFOLIUM FRUITING TOP (UNII: 147AL91LPR) (ILEX AQUIFOLIUM FRUITING TOP - UNII:147AL91LPR) ILEX AQUIFOLIUM FRUITING 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:43857-0364-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/01/201511/03/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/201511/03/2025
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0364) , api manufacture(43857-0364) , label(43857-0364) , pack(43857-0364)
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