Label: TRAULEVIUM- arnica montana radix, calendula officinalis, hamamelis virginiana, echinacea, echinacea purpurea, chamomilla, symphytum officinale, bellis perennis, hypericum perforatum, millefolium, aconitum napellus, belladonna, mercurius solubilis, hepar sulphuris calcareum. ointment
- NDC Code(s): 70857-001-50
- Packager: Medical Technology Products, Inc.
- 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 December 29, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENTS
Active ingredients (HPUS*) Purpose** Each 50 g of ointment contains: Arnica Montana, Radix 3X 750 mg Reduces joint & back pain Calendula Officinalis MT (N) 225 mg Relieves pain Hamamelis Virginiana MT (N) 225 mg Relieves joint & muscle soreness Echinacea MT (N) 75 mg Relieves pain Echinacea Purpurea MT (N) 75 mg Relieves pain Chamomilla MT (N) 75 mg Soothing pain relief Symphytum Officinale 4X (Final concentration 6X) 50 mg Relieves joint pain Bellis Perennis MT (M) 50 mg Relieves joint & muscle soreness Hypericum Perforatum 6X 45 mg Relieves pain Millefolium MT (N) 45 mg Relieves pain Aconitum Napellus 1X (Final concentration 4X) 25 mg Reduces joint & back pain Belladonna 1X 25 mg Reduces back pain Mercurius Solubilis 6X 20 mg Reduces joint & back pain Hepar Sulphuris Calcareum 6X 12.5 mg Relieves pain - USES
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WARNINGS
Warnings
For external use only.
- Do not apply over open wounds or broken skin.
- If symptoms worsen or persist for more than a week, 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 Traulevium 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, consult a healthcare provider before use.
- Contraindications: Known allergy (hypersensitivity) to one of the ingredients, including plants of the daisy family (Asteraceae) such as Arnica montana (arnica), Calendula officinalis (pot marigold), Chamomilla (German chamomile), Echinacea (coneflower), Achillea millefolium (yarrow), Bellis perennis (daisy) and emulsifying cetylstearyl alcohol.
- DIRECTIONS
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OTHER INFORMATION
Other information
Tamper evident: Do not use if protective seal under cap is broken. Store at room temperature. Protect from light. Please retain outer carton for full product instructions.
**These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.
*The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
- INACTIVE INGREDIENTS
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QUESTIONS?
Questions?
Call 1.866.440.7703 or e-mail info@traulevium.com
Made in the USA.
Manufactured exclusively for Medical Technology Products, Inc. by OHM pharma Inc.
Medical Technology Products, Inc.
Riviera Beach, FL 33407, USA.
- PACKAGE LABELING
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INGREDIENTS AND APPEARANCE
TRAULEVIUM
arnica montana radix, calendula officinalis, hamamelis virginiana, echinacea, echinacea purpurea, chamomilla, symphytum officinale, bellis perennis, hypericum perforatum, millefolium, aconitum napellus, belladonna, mercurius solubilis, hepar sulphuris calcareum. ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70857-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 3 [hp_X] in 50 g CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 225 mg in 50 g HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 225 mg in 50 g ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 75 mg in 50 g ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 75 mg in 50 g MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 75 mg in 50 g COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 6 [hp_X] in 50 g BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 50 mg in 50 g HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 6 [hp_X] in 50 g ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 45 mg in 50 g ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 4 [hp_X] in 50 g ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 1 [hp_X] in 50 g MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 6 [hp_X] in 50 g CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_X] in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PETROLATUM (UNII: 4T6H12BN9U) PARAFFIN (UNII: I9O0E3H2ZE) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70857-001-50 1 in 1 BOX 10/12/2016 1 50 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 10/12/2016 Labeler - Medical Technology Products, Inc. (150890841)
