Hevert Trauma Roll-on Gel
FDA Label NDC 54532-0024

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hevert Arzneimittel Gmbh & Co Kg for the product Hevert Trauma Roll-on (NDC 54532-0024). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Hevert Pharmaceuticals, LLC
Boulder, CO 80301

Otc - Purpose

Active ingredientsPurpose
Arnica montana, radix 3X

Relief of minor aches and pains

Bellis perennis 1X
Calendula officinalis 1X
Hamamelis virginiana 1X
Hypericum perforatum 6X
Millefolium 1X
Ruta graveolens 4X
Symphytum officinale 6X

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

Uses

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

  • muscle pain and stiffness
  • bruising and swelling

    • These statements have not been evaluated by the Food and Drug Administration. They are supported by traditional homeopathic principles.

Warnings

For external use only

Otc - Do Not Use

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

When using this product

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

Otc - Stop Use

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

Keep out of reach of children.

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

Directions

  • 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

  • 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

hydroxypropyl cellulose, isopropyl alcohol, purified water

Questions?

1-855-387-6466

Principal Display Panel - 50 Ml Bottle Carton

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)

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