Label: TRAULEVIUM PAIN RELIEF GEL- arnica montana, calendula officinalis, hamamelis virginiana, echinacea, echinacea purpurea, chamomilla, symphytum officinale, bellis perennis, hypericum perforatum, millefolium, aconitum napellus, belladonna, mercurius solubilis, hepar sulphuris calcareum. gel
- NDC Code(s): 70857-004-16
- 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)
-
ACTIVE INGREDIENTS
Active ingredients (HPUS*) Purpose** Each 100 g of gel contains: Arnica Montana, Radix 3X 1500 mg Reduces joint & back pain Calendula Officinalis MT (N) 450 mg Relieves pain Hamamelis Virginiana MT (N) 450 mg Relieves joint & muscle soreness Echinacea MT (N) 150 mg Relieves pain Echinacea Purpurea MT (N) 150 mg Relieves pain Chamomilla MT (N) 150 mg Soothing pain relief Symphytum Officinale 4X (Final concentration 6X) 100 mg Relieves joint pain Bellis Perennis MT (M) 100 mg Relieves joint & muscle soreness Hypericum Perforatum 6X 90 mg Relieves pain Millefolium MT (N) 90 mg Relieves pain Aconitum Napellus 1X (Final concentration 4X) 50 mg Reduces joint & back pain Belladonna 1X 50 mg Reduces back pain Mercurius Solubilis 6X 40 mg Reduces joint & back pain Hepar Sulphuris Calcareum 6X 25 mg Relieves pain - USES
-
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.
- DIRECTIONS
-
OTHER INFORMATION
Other information
Tamper evident: Do not use if protective seal around the pump is broken or missing. Store at room temperature. Protect from light.
**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
-
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.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TRAULEVIUM PAIN RELIEF GEL
arnica montana, calendula officinalis, hamamelis virginiana, echinacea, echinacea purpurea, chamomilla, symphytum officinale, bellis perennis, hypericum perforatum, millefolium, aconitum napellus, belladonna, mercurius solubilis, hepar sulphuris calcareum. gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70857-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_X] in 100 g CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 0.45 g 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 0.45 g in 100 g ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 0.15 g in 100 g ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 0.15 g in 100 g MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 0.15 g in 100 g COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 6 [hp_X] in 100 g BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 0.1 g in 100 g HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 6 [hp_X] in 100 g ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 0.09 g in 100 g ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 4 [hp_X] in 100 g ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 1 [hp_X] in 100 g MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 6 [hp_X] in 100 g CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_X] in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70857-004-16 454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/19/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/19/2016 Labeler - Medical Technology Products, Inc. (150890841)
