Traumeel: Homeopathic Product Information

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

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.

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

Add image transcription here…

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 Type HUMAN OTC DRUG Item Code (Source) NDC:62795-9488 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 4 [hp_X] ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED 2 [hp_X] ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 3 [hp_X] ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT 2 [hp_X] BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS 2 [hp_X] CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 2 [hp_X] CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 8 [hp_X] HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM 2 [hp_X] COMFREY ROOT (COMFREY ROOT) COMFREY ROOT 8 [hp_X] MATRICARIA RECUTITA (MATRICARIA CHAMOMILLA) MATRICARIA RECUTITA 3 [hp_X] HAMAMELIS VIRGINIANA LEAF (HAMAMELIS VIRGINIANA LEAF) HAMAMELIS VIRGINIANA LEAF 2 [hp_X] ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA 2 [hp_X] MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 8 [hp_X] ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM 3 [hp_X]

Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE

Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code H Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62795-9488-2 1 BOTTLE in 1 CARTON contains a BOTTLE 1 100 TABLET in 1 BOTTLE This package is contained within the CARTON (62795-9488-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/24/2022

Labeler — MediNatura Inc (079324099)

Establishment
Name	Address	ID/FEI	Operations
Biologische Heilmittel		315635359	manufacture (62795-9488)

Revised: 07/2022 MediNatura Inc