Hevert Trauma Roll-On

Manufacturer
Hevert Arzneimittel GmbH & Co KG | Hevert Arzneimittel GmbH & Co. KG
Effective date
2022-12-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:18:56

Label at a glance#

ProductHevert Trauma Roll-On
Active ingredientARNICA MONTANA ROOT, BELLIS PERENNIS WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM WHOLE, ACHILLEA MILLEFOLIUM FLOWERING TOP, RUTA GRAVEOLENS FLOWERING TOP, COMFREY ROOT
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains, such as: muscle pain and stiffness bruising and swelling Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated .

Dosage and administration

For external use only Adults and children over 6 years of age: Apply a thin layer of this product to the affected area 3–4 times daily.

Storage and handling

Store at 68 to 77 °F, lid closed tightly. Keep away from excessive heat or open flame. To report serious adverse events, call 1-855-387-6466

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Arnica montana, radix 3X*
Bellis perennis 1X*
Calendula officinalis 1X*
Hamamelis virginiana 1X*
Hypericum perforatum 6X*
Millefolium 1X*
Ruta graveolens 4X*
Symphytum officinale 6X*

* Relief of minor aches and pains

"X" indicates a homeopathic dilution. For more information visit: www.hevertusa.com

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains, such as:

  • muscle pain and stiffness
  • bruising and swelling

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use if

  • you are allergic to Arnica montana, Calendula officinalis (common marigold) or other plants from the daisy family (Compositae), or to any of the ingredients of this product

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes or mucous membranes
  • do not apply to wounds, damaged or irritated skin

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition persists for more than 3 days or gets worse
  • new symptoms occur

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For external use only
  • Adults and children over 6 years of age:
    Apply a thin layer of this product to the affected area 3–4 times daily.

Other information

STORAGE AND HANDLING SECTION

  • Store at 68 to 77 °F, lid closed tightly.
  • Keep away from excessive heat or open flame.
  • To report serious adverse events, call 1-855-387-6466

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydroxypropyl cellulose, isopropyl alcohol, purified water

Questions?

OTC - QUESTIONS SECTION

1-855-387-6466

SPL UNCLASSIFIED SECTION

Distributed by:
Hevert Pharmaceuticals, LLC
Boulder, CO 80303

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54532-0024-5

HEVERT®
TRAUMA

Roll-
On

Homeopathic topical
pain relieving gel

Gentle relief from minor
aches and pains

With the power of Arnica !

1.7 fl oz (50 mL)

hEVERT

Principal Display Panel - 50 mL Bottle Carton
Principal Display Panel - 50 mL Bottle Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54532-0024-5Hevert Trauma Roll-On1 in 1 CARTONGEL14
54532-0024-5Hevert Trauma Roll-On50 mL in 1 BOTTLE, WITH APPLICATORGEL504
54532-0024-6Hevert Trauma Roll-On10 mL in 1 BOTTLE, WITH APPLICATORGEL104
54532-0024-6Hevert Trauma Roll-On1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54532-0024HEVERT TRAUMA ROLL-ON (ARNICA MONTANA ROOT, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM FLOWERING TOP, RUTA GRAVEOLENS FLOWERING TOP, AND COMFREY ROOT) GEL [HEVERT ARZNEIMITTEL GMBH & CO KG]4Current NDC, Legacy NDC, 4 package rows20221217_dce69e3b-e080-459c-a444-4f84322a7f89.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54532-002454532-0024-5, 54532-0024-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
Hevert Trauma Roll-OnARNICA MONTANA ROOT, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM FLOWERING TOP, RUTA GRAVEOLENS FLOWERING TOP, AND COMFREY ROOTHevert Arzneimittel GmbH & Co KGdce69e3b-e080-459c-a444-4f84322a7f892022-12-15WarningsExact identifier
ndc (package): 54532-0024-5
ndc (package): 54532-0024-6
ndc (product): 54532-0024
ndc11 (package): 54532002406
ndc11 (package): 54532002405
spl id: 5d3766e3-586c-4cf0-89c1-fc7c0c1138b5
spl set id: dce69e3b-e080-459c-a444-4f84322a7f89

Reported adverse events (FAERS/openFDA)#

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