Label: 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

  • NDC Code(s): 54532-0024-5, 54532-0024-6
  • Packager: Hevert Arzneimittel GmbH & Co KG
  • 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 15, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    *
    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

  • SPL UNCLASSIFIED SECTION

    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

    Principal Display Panel - 50 mL Bottle Carton
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54532-0024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [hp_X]  in 1 mL
    BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS WHOLE - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE1 [hp_X]  in 1 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [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 BARK1 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM WHOLE - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE6 [hp_X]  in 1 mL
    ACHILLEA MILLEFOLIUM FLOWERING TOP (UNII: 55862Q3XEU) (ACHILLEA MILLEFOLIUM FLOWERING TOP - UNII:55862Q3XEU) ACHILLEA MILLEFOLIUM FLOWERING TOP1 [hp_X]  in 1 mL
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP4 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOW (weak yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54532-0024-51 in 1 CARTON04/01/2016
    150 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:54532-0024-61 in 1 CARTON04/01/2016
    210 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/01/2016
    Labeler - Hevert Arzneimittel GmbH & Co KG (318100617)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hevert Arzneimittel GmbH & Co. KG318100617MANUFACTURE(54532-0024)
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