Label: BACH ORIGINAL FLOWER REMEDIES HOLLY- ilex aquifolium fruiting top solution

  • NDC Code(s): 57687-264-20
  • Packager: Nelson Bach USA Limited
  • 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 27, 2020

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  • Indications

    For relief of naturally occurring simple nervous tension.

  • Directions

    Take 2 drops in mouth or in water, sip at intervals. Repeat as needed.

  • Warnings

    Keep out of reach of children.

    If pregnant or breast-feeding, ask a health professional before use.

  • Active Ingredients

    5 × dilution of Ilex aquifolium HPUS.

  • Inactive Ingredients

    27% Alcohol.

  • QUESTIONS

    Satisfaction guaranteed, call 1-800-319-9151 if unsatisfied for complete refund.

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Nelson Bach USA, Ltd.,
    Andover, MA 01845

  • PRINCIPAL DISPLAY PANEL - 20 mL Bottle Label

    Bach®
    ORIGINAL
    FLOWER REMEDIES

    HOLLY
    Goodwill Towards Others*

    20 mL (0.7 fl oz)
    HOMEOPATHIC
    CONTAINS 27% ALCOHOL

    PRINCIPAL DISPLAY PANEL - 20 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BACH ORIGINAL FLOWER REMEDIES HOLLY 
    ilex aquifolium fruiting top solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57687-264
    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 Top5 [hp_X]  in 0.095 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57687-264-2020 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/01/2002
    Labeler - Nelson Bach USA Limited (877720193)
    Registrant - A. Nelson & Co. Limited (221471234)
    Establishment
    NameAddressID/FEIBusiness Operations
    A. Nelson & Co Ltd221471234MANUFACTURE(57687-264) , PACK(57687-264) , LABEL(57687-264) , ANALYSIS(57687-264)
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