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 gel 
Heel 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.

----------

Traumeel 250g Gel

ACTIVE INGREDIENTS

Active ingredients: Each 250 g contains: Aconitum napellus 3X, Arnica montana, radix 3X, Belladonna 3X, Bellis perennis 1X, Calendula officinalis 1X, Chamomilla 1X, Echinacea 1X, Echinacea purpurea 1X, Hamamelis virginiana 1X, Hepar sulphuris calcareum 8X, Hypericum perforatum 6X, Mercurius solubilis 8X, Millefolium 1X, Symphytum officinale 4X.

PURPOSE

Joint Pain, Back Pain, Muscular Pain

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS AND USAGE

WARNINGS

For external use only. Do not apply over open wounds or broken skin. If symptoms persist or worsen, or if a rash develops, a healthcare provider 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. 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 healthcare provider before use.

DOSAGE AND ADMINISTRATION

Directions: Adults and children 4 years and older: Apply generously to affected areas 2 - 3 times daily, or more often if necessary. Massage thoroughly into the skin. If appropriate, mild compression or occlusive bandaging may be applied. For children under 4, consult your healthcare provider.

INACTIVE INGREDIENTS

Inactive ingredients:Carbopol 980, ethanol, purified water and sodium hydroxide.

Traumeel 250g Gel (red).jpg

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 gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50114-8015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 250 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 [hp_X]  in 250 g
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [hp_X]  in 250 g
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 250 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]  in 250 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS1 [hp_X]  in 250 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA1 [hp_X]  in 250 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED1 [hp_X]  in 250 g
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA1 [hp_X]  in 250 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM1 [hp_X]  in 250 g
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE8 [hp_X]  in 250 g
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS8 [hp_X]  in 250 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT4 [hp_X]  in 250 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM6 [hp_X]  in 250 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-8015-4250 g in 1 TUBE; Type 0: Not a Combination Product10/31/199904/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/31/199904/30/2014
Labeler - Heel Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Heel Belgium282761204manufacture(50114-8015)

Revised: 5/2018
Document Id: 8b20b707-abd9-4b7e-9a7a-6c7e95257489
Set id: ee11ed80-fe85-44e5-8498-ae59fe3d764b
Version: 3
Effective Time: 20180523
 
Heel Inc