Label: TRAUMEEL- atropa belladonna,echinacea, unspecified,arnica montana root,aconitum napellus,bellis perennis,calendula officinalis flowering top,calcium sulfide,hypericum perforatum,comfrey root,matricaria recutita,hamamelis virginiana leaf,echinacea purpurea,mercurius solubilis,achillea millefolium tablet

  • 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, 2023

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  • Indications:

    For the temporary relief of
    muscular pain, joint pain, and pain from
    minor sports injuries and bruises.

  • Warnings:

    If pregnant or breast-feeding,
    ask a health professional before use. Keep
    out of reach of children. If symptoms persist
    or worsen, a healthcare provider should be
    consulted. Do not use if known sensitivity to
    Traumeel® or any of its ingredients exists

  • Directions:

    Adults and children 4 years
    and older: 1-2 tablets 3 times per day or as
    directed by a health practitioner. Not to exceed
    6 tablets per 24 hours. Children under 4, as
    directed by a health professional. Allow to
    completely dissolve in the mouth.

  • Inactive ingredients:


    Lactose, Magnesium sterate

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Purpose

    Analgesic

  • Active ingredients:

    Each 300 g tablet
    contains: *Arnica montana, radix 2X 15mg;
    *Calendula officinalis 2X 15mg; *Hamamelis
    virginiana 2X 15mg; *Bellis perennis 2X 6mg;
    *Echinacea 2X 6mg; *Echinacea purpurea 2X 6mg;
    *Hypericum perforatum 2X 3mg; *Aconitum
    napellus 3X 30mg; *Chamomilla 3X 24mg;
    *Millefolium 3X 15mg; *Belladonna 4X 75mg;
    Hepar sulphuris calcareum 8X 30mg; Mercurius
    solubilis 8X 30mg; *Symphytum officinale 8X 24mg.
    *Natural Ingredients

  • PRINCIPAL DISPLAY PANEL

    Traumeel

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  • INGREDIENTS AND APPEARANCE
    TRAUMEEL 
    atropa belladonna,echinacea, unspecified,arnica montana root,aconitum napellus,bellis perennis,calendula officinalis flowering top,calcium sulfide,hypericum perforatum,comfrey root,matricaria recutita,hamamelis virginiana leaf,echinacea purpurea,mercurius solubilis,achillea millefolium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-9488
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [hp_X]
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED2 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT2 [hp_X]
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS2 [hp_X]
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP2 [hp_X]
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE8 [hp_X]
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM2 [hp_X]
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT8 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV) HAMAMELIS VIRGINIANA LEAF2 [hp_X]
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 [hp_X]
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS8 [hp_X]
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-9488-21 in 1 CARTON01/24/2022
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/24/2022
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biologische Heilmittel315635359manufacture(62795-9488)
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