HEVERT 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 Trauma Roll-On by

Drug Labeling and Warnings

Hevert Trauma Roll-On by is a Homeopathic medication manufactured, distributed, or labeled by Hevert Arzneimittel GmbH & Co KG, Hevert Arzneimittel GmbH & Co. KG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
* Relief of minor aches and pains
Arnica montana, radix 3X	*
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

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

Warnings

For external use only

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

When using this product

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

Stop use and ask a doctor if

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

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

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Distributed by:
Hevert Pharmaceuticals, LLC
Boulder, CO 80303

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

INGREDIENTS AND APPEARANCE

HEVERT 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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54532-0024
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 1 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	1 [hp_X]  in 1 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 1 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	1 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [hp_X]  in 1 mL
ACHILLEA MILLEFOLIUM FLOWERING TOP (UNII: 55862Q3XEU) (ACHILLEA MILLEFOLIUM FLOWERING TOP - UNII:55862Q3XEU)	ACHILLEA MILLEFOLIUM FLOWERING TOP	1 [hp_X]  in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	4 [hp_X]  in 1 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW (weak yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54532-0024-5	1 in 1 CARTON	04/01/2016
1		50 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 54532-0024-6	1 in 1 CARTON	04/01/2016
2		10 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		04/01/2016

Labeler - Hevert Pharmaceuticals LLC (078647622)

Registrant - Hevert Arzneimittel GmbH & Co. KG (318100617)

Establishment
Name	Address	ID/FEI	Business Operations
Hevert Arzneimittel GmbH & Co. KG		318100617	MANUFACTURE(54532-0024)