Label: TRAUMEEL- aconitum napellus, arnica montana root, atropa belladonna, bellis perennis, calendula officinalis flowering top, matricaria recutita, echinacea, unspecified, echinacea purpurea, hamamelis virginiana root bark/stem bark, calcium sulfide, hypericum perforatum, mercurius solubilis, achillea millefolium and comfrey root ointment
- NDC Code(s): 51885-9487-8
- Packager: Biologische Heilmittel Heel
- 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 March 6, 2023
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ACTIVE INGREDIENTS
Active ingredients: Each 100 g contains:
*Aconitum napellus 1X 0.050g; *Arnica montana, radix 3X 1.50g; *Belladonna 1X 0.050g; *Bellis perennis MT 0.100g; *Calendula officinalis MT 0.450g; *Chamomilla MT 0.150g; *Echinacea MT 0.150g; *Echinacea purpurea MT 0.150g; *Hamamelis virginiana MT 0.450g; Hepar sulphuris calcareum 6X 0.025g; *Hypericum perforatum 6X 0.090g; Mercurius solubilis 6X 0.040g; *Millefolium MT 0.090g; *Symphytum officinale 4X 0.100g.
*Natural Ingredients
- PURPOSE
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Warning
Warnings: For external use only. Cetylstearyl alcohol may cause local skin reactions, i.e.
contact dermatitis. Do not apply over large areas of the body. Do not apply over open wounds or
broken skin. If symptoms persist or worsen, or if a rash develops, a physician should be consulted.
Do not use if known sensitivity to Traumeel® ointment or any of its ingredients exists. Keep out of
reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, ask a health professional before use. -
Directions
Directions: Adults and children 4 years and older: Apply generously to affected areas 2 to 3 times daily, or as directed
by your health professional. Massage thoroughly into skin. Traumeel® may be applied using mild compression bandaging
and/or occlusive bandaging. For children under 4, use as directed by your health professional. - INACTIVE INGREDIENTS
- KEEP OUT OF REACH OF CHILDREN
- Indications
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRAUMEEL
aconitum napellus, arnica montana root, atropa belladonna, bellis perennis, calendula officinalis flowering top, matricaria recutita, echinacea, unspecified, echinacea purpurea, hamamelis virginiana root bark/stem bark, calcium sulfide, hypericum perforatum, mercurius solubilis, achillea millefolium and comfrey root ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51885-9487 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 1 [hp_X] in 1 g ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 3 [hp_X] in 1 g ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 1 [hp_X] in 1 g BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 1 [hp_X] in 1 g CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 1 g MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 1 [hp_X] in 1 g ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 1 [hp_X] in 1 g ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 1 [hp_X] in 1 g HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X] in 1 g CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_X] in 1 g HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 6 [hp_X] in 1 g MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 6 [hp_X] in 1 g ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 1 [hp_X] in 1 g COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 4 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) PARAFFIN (UNII: I9O0E3H2ZE) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51885-9487-8 1 in 1 CARTON 09/20/2021 1 100 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/20/2021 Labeler - Biologische Heilmittel Heel (315635359) Establishment Name Address ID/FEI Business Operations Biologische Heilmittel Heel 315635359 manufacture(51885-9487)
