Label: NEUROTONE (passiflora incarnata, glandula suprarenalis suis, thyroidinum- suis, arnica montana, hypericum perforatum, lachesis mutus, muira puama liquid

  • NDC Code(s): 43857-0187-1
  • 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 December 7, 2016

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  • ACTIVE INGREDIENTS:

    Passiflora Incarnata 3X, Glandula Suprarenalis Suis 8X, Thyroidinum (Suis) 8X, Arnica Montana 12X, Hypericum Perforatum 12X, Lachesis Mutus 12X, Muira Puama 15X.

  • INDICATIONS:

    For temporary relief of numbness and tingling; stiffness in nape of the neck and shooting pains with tingling, and burning pain and numbness. 

  • 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.

  • DIRECTIONS:

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

  • INACTIVE INGREDIENTS:

    Demineralized water, 25% Ethanol.

  • 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.

  • INDICATIONS:

    For temporary relief of numbness and tingling; stiffness in nape of the neck and shooting pains with tingling, and burning pain and numbness.

  • QUESTIONS:

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

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    NEUROTONE

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Neurotone

  • INGREDIENTS AND APPEARANCE
    NEUROTONE 
    passiflora incarnata, glandula suprarenalis suis, thyroidinum (suis), arnica montana, hypericum perforatum, lachesis mutus, muira puama liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0187
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 1 mL
    SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND8 [hp_X]  in 1 mL
    SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ) SUS SCROFA THYROID8 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA12 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM12 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 1 mL
    PTYCHOPETALUM OLACOIDES ROOT (UNII: 20ZOM5K94D) (PTYCHOPETALUM OLACOIDES ROOT - UNII:20ZOM5K94D) PTYCHOPETALUM OLACOIDES ROOT15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0187-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product12/07/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/11/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0187) , api manufacture(43857-0187) , label(43857-0187) , pack(43857-0187)
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