Label: DERCUTION- centella asiatica, ranunculus bulbosus, delphinium staphisagria seed, calendula officinalis flowering top, echinacea, unspecified, rhododendron tomentosum leafy twig, and viola tricolor lotion

  • NDC Code(s): 59469-327-60
  • 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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  • SPL UNCLASSIFIED SECTION

    Drug facts

  • ACTIVE INGREDIENT

    Active ingredients
    Hydrocotyle asiatica3X
    Ranunculus bulbosus4X
    Staphysagria6X
    Calendula officinalis8X
    Echinacea8X
    Ledum palustre4X
    Viola tricolor4X
  • Uses

    For sunburn, insect bites, skin rashes, and itching due to skin irritation. 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.

  • Warnings

    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.

  • Directions

    This lotion was developed for use on large skin surface areas.

    Unless otherwise prescribed, apply a moderate amount of lotion 2 to 3 times per day by rubbing gently into the affected area.

    For external use only. Do not use on open wounds!

  • Other information

    Protect from light and heat.

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

  • Inactive ingredients

    Purified water, cetylstearyl alcohol, glycerol, triglycerides. Selected ingredients prepared by spagyric processes.

  • QUESTIONS

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

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    PEKANA® GmbH
    D-88353 Kisslegg

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

  • PRINCIPAL DISPLAY PANEL - 60 g Bottle Box

    DerCution
    Homeopathic Lotion

    For sunburn, insect
    bites, skin rashes,
    and itching due to skin
    irritation

    2.1 OZ
    (60 g)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 60 g Bottle Box
  • INGREDIENTS AND APPEARANCE
    DERCUTION 
    centella asiatica, ranunculus bulbosus, delphinium staphisagria seed, calendula officinalis flowering top, echinacea, unspecified, rhododendron tomentosum leafy twig, and viola tricolor lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-327
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) (CENTELLA ASIATICA WHOLE - UNII:7M867G6T1U) CENTELLA ASIATICA WHOLE3 [hp_X]  in 100 g
    RANUNCULUS BULBOSUS WHOLE (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS WHOLE - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS WHOLE4 [hp_X]  in 100 g
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED6 [hp_X]  in 100 g
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP8 [hp_X]  in 100 g
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED8 [hp_X]  in 100 g
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG4 [hp_X]  in 100 g
    VIOLA TRICOLOR WHOLE (UNII: 9Q24RAI43V) (VIOLA TRICOLOR WHOLE - UNII:9Q24RAI43V) VIOLA TRICOLOR WHOLE4 [hp_X]  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-327-601 in 1 BOX01/21/2020
    160 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/21/2020
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-327)
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