Label: BACH ORIGINAL FLOWER REMEDIES MIMULUS- mimulus guttatus flowering top solution

  • NDC Code(s): 57687-219-10
  • 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 September 26, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Mimulus (Mimulus guttatus) 5X HPUS

    ‘HPUS’ indicates the ingredient is in the official Homeopathic Pharmacopoeia of the United States

  • Purpose

    Face your fears

  • Use

    For relief of naturally occurring simple nervous tension

  • Warnings

    Consult a doctor if symptoms last for more than 7 days or worsen

    Keep out of reach of children

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

  • Directions

    Take 2 drops directly on the tongue or add to a beverage & sip. Repeat as needed throughout the day.

    Children under 2: ask a doctor before use.

  • Other Information

    Store below 77° (25°C)

    Do not use if tamper-evident seal around bottle neck is missing or broken

  • Inactive Ingredients

    glycerin [vegetable], purified water

  • Questions

    800-319-9151 8am-5pm (EST) Mon-Fri

  • PRINCIPAL DISPLAY PANEL

    Bach Original Flower Remedies Mimulus

  • INGREDIENTS AND APPEARANCE
    BACH ORIGINAL FLOWER REMEDIES MIMULUS 
    mimulus guttatus flowering top solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57687-219
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MIMULUS GUTTATUS FLOWERING TOP (UNII: 192426I5JU) (MIMULUS GUTTATUS FLOWERING TOP - UNII:192426I5JU) MIMULUS GUTTATUS FLOWERING TOP5 [hp_X]  in 0.095 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57687-219-101 in 1 CARTON09/20/2022
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/20/2022
    Labeler - Nelson Bach USA Limited (877720193)
    Registrant - A. Nelson & Co. Limited (221471234)
    Establishment
    NameAddressID/FEIBusiness Operations
    A. Nelson & Co. Limited221471234manufacture(57687-219)