FDA.reportPublic FDA data

Traulevium Pain Relief Gel

Manufacturer
Medical Technology Products, Inc.
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:15:22

Label at a glance#

ProductTraulevium Pain Relief Gel
Active ingredientARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, MATRICARIA RECUTITA, COMFREY ROOT, BELLIS PERENNIS, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, ACONITUM NAPELLUS, ATROPA BELLADONNA, MERCURIUS SOLUBILIS, CALCIUM SULFIDE
Label structure8 sections

Indications and uses

Uses** For the temporary relief of: Joint Pain Back Pain Muscular Pain

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

 
  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

INDICATIONS & USAGE SECTION

Uses** For the temporary relief of:

  • Joint Pain
  • Back Pain
  • Muscular Pain

WARNINGS

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

 
Adults and children 4 years and olderApply generously to affected areas 2 to 3 times daily, or more often if necessary. Massage thoroughly into the skin. If appropriate, mild compression or occlusive bandaging may be applied. 
Children under 4Consult your healthcare provider.

 

OTHER INFORMATION

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Carbopol 980, ethanol, purified water and sodium hydroxide.

QUESTIONS?

OTC - QUESTIONS SECTION

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.

www.traulevium.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70857-004-16

Traulevium ™

Pain Relief Gel

Homeopathic Medicine

Compare to Traumeel®. Traumeel is a brand name owned by Biologische Heilmittel Heel GmbH. Traulevium is not associated with the brand owner.

Net Wt. 16oz (454 g)

16oz bottle label16oz bottle label

OTC - PURPOSE SECTION

Pain Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70857-004-16TrauleviumPain Relief Gel454 g in 1 BOTTLE, PUMPGEL4545

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70857-004TRAULEVIUM 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 [MEDICAL TECHNOLOGY PRODUCTS, INC.]5Current NDC, Legacy NDC, 1 package rows20211230_692daf7a-11e2-4f08-bdcf-1b9ac866d213.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70857-00470857-004-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SODIUM HYDROXIDE55X04QC32IIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
ARNICA MONTANAO80TY208ZWACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
COMFREY ROOTM9VVZ08EKQACTIB
BELLIS PERENNIS2HU33I03UYACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Traulevium Pain Relief GelARNICA MONTANA, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.Medical Technology Products, Inc.692daf7a-11e2-4f08-bdcf-1b9ac866d2132021-12-29WarningsExact identifier
ndc (package): 70857-004-16
ndc (product): 70857-004
ndc11 (package): 70857000416
spl id: d44c63cf-1825-746a-e053-2a95a90adf65
spl set id: 692daf7a-11e2-4f08-bdcf-1b9ac866d213

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.