Label: SALSOLINOL (salsolinol- hydrochloride liquid

  • NDC Code(s): 43857-0501-1
  • 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, 2018

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  • ACTIVE INGREDIENTS:

    Salsolinol (Hydrochloride) 6X, 12X, 30X, 12C, 30C.

  • INDICATIONS:

    For temporary relief of elbow pain, headaches, craving for chocolate, confusion, sinus pressure and weakness.

  • 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 elbow pain, headaches, craving for chocolate, confusion, sinus pressure and weakness.

  • 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
    SALSOLINOL
    HOMEOPATHIC
    1 FL OZ (30 ml)

    Salsolinol

  • INGREDIENTS AND APPEARANCE
    SALSOLINOL 
    salsolinol (hydrochloride) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0501
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALSOLINOL HYDROCHLORIDE, (+/-)- (UNII: 1C0F27WEAL) (SALSOLINOL HYDROCHLORIDE, (+/-)- - UNII:1C0F27WEAL) SALSOLINOL HYDROCHLORIDE, (+/-)-6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0501-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product12/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/07/2018
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0501) , api manufacture(43857-0501) , label(43857-0501) , pack(43857-0501)
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