Label: TRAUMED- arnica montana whole, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark,baptisia tinctoria root, bellis perennis whole, echinacea angustifolia whole,aconitum napellus whole,matricaria chamomilla whole,achillea millefolium whole,atropa belladonna,hypericum perforatum whole,ruta graveolens flowering top and comfrey root tablet, chewable

  • 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 March 21, 2023

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  • Uses:

     For the temporary relief of minor pain due to overexertion,
    bruising, minor injuries.–

  • Warnings:

     If pregnant or breast-feeding, ask a health
    professional before use. Keep out of reach of children.
    If symptoms persist or worsen, a health professional
    should be consulted. Do not use if known sensitivity to
    BHI Traumed® or any of its ingredients exists.–

  • Directions:

     At first sign of symptoms: Adults and children 4 years
    and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then
    continue with standard dosage. Standard dosage: Adults and
    children 4 years and older: 3 tablets per day, taking 1 tablet every
    4-6 hours. Do not exceed 12 tablets in 24 hours. For children
    under 4 years, consult your health professional. Allow tablets to
    dissolve completely in the mouth, do not swallow

  • Keep out of reach of children.

    Keep out of reach of children.

  • Purpose

    Pain Relief

  • Active Ingredients:

     Each tablet contains: *Arnica
    montana 3X 150mg, *Calendula officinalis 2X 10mg,
    *Hamamelis virginiana 2X 10mg, *Baptisia tinctoria
    2X 6mg, *Bellis perennis 2X 6mg, *Echinacea 2X 6mg,
    *Aconitum napellus 3X 30mg, *Chamomilla 2X 3mg,
    *Millefolium 2X 2mg, *Belladonna 3X 8mg, *Hypericum
    perforatum 3X 8mg, *Ruta graveolens 4X 10mg,
    *Arnica montana 6X 21mg, *Symphytum officinale 8X
    24mg, *Arnica montana 10X 6mg. *Natural

  • Inactive Ingredients

     Dextrose, Magnesium
    stearate, Maltodextrin

  • PRINCIPAL DISPLAY PANEL

    Traumed

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    TRAUMED 
    arnica montana whole, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark,baptisia tinctoria root, bellis perennis whole, echinacea angustifolia whole,aconitum napellus whole,matricaria chamomilla whole,achillea millefolium whole,atropa belladonna,hypericum perforatum whole,ruta graveolens flowering top and comfrey root tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-2303
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE3 [hp_X]
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP2 [hp_X]
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X]
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT2 [hp_X]
    BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE2 [hp_X]
    ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE2 [hp_X]
    ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE3 [hp_X]
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE2 [hp_X]
    ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM WHOLE2 [hp_X]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]
    HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE3 [hp_X]
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP4 [hp_X]
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT8 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Dextrose (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code radiantman
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-2303-260 in 1 BOTTLE; Type 0: Not a Combination Product03/21/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/21/2023
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc102783016manufacture(62795-2303)
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