NDC Code(s) : 51885-7125-3, 51885-7125-1, 51885-7125-6
Packager : Biologische Heilmittel Heel

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Traumeel X CALENDULA OFFICINALIS FLOWERING TOP and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and ARNICA MONTANA ROOT and ACONITUM NAPELLUS and ATROPA BELLADONNA and BELLIS PERENNIS and MATRICARIA RECUTITA and ECHINACEA, UNSPECIFIED and ECHINACEA PURPUREA and ACHILLEA MILLEFOLIUM and CALCIUM SULFIDE and MERCURIUS SOLUBILIS and COMFREY ROOT and HYPERICUM PERFORATUM and OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51885-7125
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALENDULA OFFICINALIS FLOWERING TOP(UNII: 18E7415PXQ)
(CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) 		CALENDULA OFFICINALIS FLOWERING TOP1 g in 50 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK(UNII: T7S323PKJS)
(HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) 		HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 g in 50 g
ARNICA MONTANA ROOT(UNII: MUE8Y11327)
(ARNICA MONTANA ROOT - UNII:MUE8Y11327) 		ARNICA MONTANA ROOT3 [hp_X] in 50 g
ACONITUM NAPELLUS(UNII: U0NQ8555JD)
(ACONITUM NAPELLUS - UNII:U0NQ8555JD) 		ACONITUM NAPELLUS1 [hp_X] in 50 g
ATROPA BELLADONNA(UNII: WQZ3G9PF0H)
(ATROPA BELLADONNA - UNII:WQZ3G9PF0H) 		ATROPA BELLADONNA1 [hp_X] in 50 g
BELLIS PERENNIS(UNII: 2HU33I03UY)
(BELLIS PERENNIS - UNII:2HU33I03UY) 		BELLIS PERENNIS1 g in 50 g
MATRICARIA RECUTITA(UNII: G0R4UBI2ZZ)
(MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) 		MATRICARIA RECUTITA1 g in 50 g
ECHINACEA, UNSPECIFIED(UNII: 4N9P6CC1DX)
(ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) 		ECHINACEA, UNSPECIFIED1 g in 50 g
ECHINACEA PURPUREA(UNII: QI7G114Y98)
(ECHINACEA PURPUREA - UNII:QI7G114Y98) 		ECHINACEA PURPUREA1 g in 50 g
ACHILLEA MILLEFOLIUM(UNII: 2FXJ6SW4PK)
(ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) 		ACHILLEA MILLEFOLIUM1 g in 50 g
CALCIUM SULFIDE(UNII: 1MBW07J51Q)
(CALCIUM SULFIDE - UNII:1MBW07J51Q) 		CALCIUM SULFIDE6 [hp_X] in 50 g
MERCURIUS SOLUBILIS(UNII: 324Y4038G2)
(MERCURIUS SOLUBILIS - UNII:324Y4038G2) 		MERCURIUS SOLUBILIS6 [hp_X] in 50 g
COMFREY ROOT(UNII: M9VVZ08EKQ)
(COMFREY ROOT - UNII:M9VVZ08EKQ) 		COMFREY ROOT4 [hp_X] in 50 g
HYPERICUM PERFORATUM(UNII: XK4IUX8MNB)
(HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) 		HYPERICUM PERFORATUM6 [hp_X] in 50 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
ALCOHOL(UNII: 3K9958V90M)
WATER(UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51885-7125-350 g in 1 CARTON
2NDC:51885-7125-1100 g in 1 CARTON
3NDC:51885-7125-64 g in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 05/24/2012

PRINCIPAL DISPLAY PANEL

Traumeel X Ointment v.2.jpg