Label: DEMYC- ranunculus bulbosus, delphinium staphisagria seed, macropiper methysticum root, anagallis arvensis, calendula officinalis flowering top, and sage solution/ drops

  • NDC Code(s): 59469-306-20
  • Packager: PEKANA Naturheilmittel GmbH
  • 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 January 11, 2023

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  • ACTIVE INGREDIENT

    Active ingredients:
    Delphinium staphysagria6X
    Piper methysticum8X
    Ranunculus bulbosus5X
    Anagallis arvensis11.85 mg/ml
    Calendula officinalis40.30 mg/ml
    Salvia officinalis
    Anhydrous glycerin    		38.70 mg/ml

    Selected ingredients prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 26% alcohol by volume.

  • Indications

    For relief of minor skin fungus, such as athlete's foot. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

  • Dosage

    Unless otherwise prescribed, adults apply drops onto affected area several times per day. For external use only.

  • Warning

    If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

    Keep out of the reach of children.

    Protect from light and heat.

    Tamper Evident

    Do not use this product if tamper evident strip is broken or removed from base of cap.

  • QUESTIONS

    To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

    Manufactured by:
    PEKANA® GmbH
    D-88353 Kisslegg

  • PRINCIPAL DISPLAY PANEL - 20 ml Bottle Box

    DEMYC™

    Homeopathic
    External
    Drops

    Homeopathic
    Medicine

    For relief of
    minor skin
    fungus, such as
    athlete's foot

    0.7 OZ
    (20 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 20 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    DEMYC 
    ranunculus bulbosus, delphinium staphisagria seed, macropiper methysticum root, anagallis arvensis, calendula officinalis flowering top, and sage solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-306
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANUNCULUS BULBOSUS WHOLE (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS WHOLE - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS WHOLE5 [hp_X]  in 20 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED6 [hp_X]  in 20 mL
    PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) (PIPER METHYSTICUM ROOT - UNII:BOW48C81XP) PIPER METHYSTICUM ROOT8 [hp_X]  in 20 mL
    LYSIMACHIA ARVENSIS WHOLE (UNII: 46883LR90E) (LYSIMACHIA ARVENSIS WHOLE - UNII:46883LR90E) LYSIMACHIA ARVENSIS WHOLE237 mg  in 20 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP806 mg  in 20 mL
    SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE774 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-306-201 in 1 BOX06/24/2019
    120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC06/24/2019
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-306)
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