TRAUMEEL - 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
Biologische Heilmittel Heel

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.

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Traumeel Ointment

ACTIVE INGREDIENTS

PURPOSE

Calendula officinalis 1X 1.5 g....................Stimulates healing process

Hamamelis virginiana 1X 1.5 g.................Relieves bruised soreness

Arnica montana, radix 3X 1.5 g.................Reduces bruising

Aconitum napellus 3X 1 g.........................Reduces pain after injury

Belladonna 3X 1 g....................................Reduces pain

Bellis perennis 1X 0.5 g............................Treats bruises

Chamomilla 1X 0.5 g................................Soothing pain relief

Echinacea 1X 0.5 g..................................Immune support

Echinacea purpurea 1X 0.5 g....................Stimulates healing process

Millefolium 1X 0.3 g.................................Treats minor bleeding

Hepar sulphuris calcareum 8X 0.25 g........Stimulates injury healing

Mercurius solubilis 8X 0.12 g....................Reduces joint pain

Symphytum officinale 4X 0.1 g..................Relieves joint pain

Hypericum perforatum 6X 0.09 g...............Relieves pain

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines out of the reach of children.

INDICATIONS AND USAGE

Indications: For the temporary relief of muscular pain, joint pain, sports injuries and bruising.

WARNINGS

Warnings: For external use only. 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. In rare cases, allergic skin reactions may develop. Do not use if known sensitivity to Traumeel or any of its ingredients exists.

DOSAGE AND ADMINISTRATION

Directions: Adults, children and infants: Apply generously to affected areas 2 to 3 times daily, or as needed. Rub gently into the skin. Traumeel may be applied using mild compression bandaging and/or occlusive bandaging.

INACTIVE INGREDIENTS

Inactive ingredients:Cetylstearyl alcohol, Ethanol, Parafin, Purified water, White petrolatum

TRAUMEEL
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 OTC DRUG	Item Code (Source)	NDC:51885-3302
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X] in 100 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 100 g
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	3 [hp_X] in 100 g
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X] in 100 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_X] in 100 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	1 [hp_X] in 100 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	1 [hp_X] in 100 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	1 [hp_X] in 100 g
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	1 [hp_X] in 100 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	1 [hp_X] in 100 g
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	8 [hp_X] in 100 g
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	8 [hp_X] in 100 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	4 [hp_X] in 100 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [hp_X] in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51885-3302-1	1 in 1 CARTON	10/31/1986	09/30/2014
1		100 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:51885-3302-3	1 in 1 CARTON	10/31/1986	09/30/2014
2		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/31/1986	09/30/2014

Labeler - Biologische Heilmittel Heel (315635359)

Name	Address	ID/FEI	Business Operations
Establishment
Biologische Heilmittel Heel		315635359	manufacture(51885-3302)

Revised: 1/2017

Document Id: b917d42f-8d74-4339-9882-da6dfc8dcfa5

Set id: 361c468f-5ccc-4418-ae29-25df57863fac

Version: 2

Effective Time: 20170119

Biologische Heilmittel Heel