Traumeel Ointment RX

Traumeel Ointment RX

Drug Labeling and Warnings

Drug Details

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TRAUMEEL RX- 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 
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.

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Traumeel Ointment RX

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

 Analgesic & Anti-inflammatory

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children

INDICATIONS AND USAGE

Indications:

Traumeel ointment is an analgesic/antiflammatory homeopathic drug product indicated for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.

WARNINGS

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.

DOSAGE AND ADMINISTRATION

Standard Dosage:

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:
Paraffin, liquid, Cetostearyl alcohol (type A), emulsifying, Paraffin, white soft, Ethanol (96 per cent)

Traumeel Rx ointment.jpg
TRAUMEEL RX 
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
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 50114-9482
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS1 [hp_X]  in 1 g
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [hp_X]  in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA1 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS1 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA1 [hp_X]  in 1 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED1 [hp_X]  in 1 g
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA1 [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 BARK1 [hp_X]  in 1 g
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM6 [hp_X]  in 1 g
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS6 [hp_X]  in 1 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM1 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT4 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50114-9482-81 in 1 CARTON04/28/2016
1100 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 50114-9482-64 g in 1 TUBE; Type 0: Not a Combination Product04/28/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/28/2016
Labeler - MediNatura Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Biologische Heilmittel Heel315635359manufacture(50114-9482)

Revised: 10/2019
 
MediNatura Inc


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