Label: TRAUMED- arnica root tablet

  • 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 October 11, 2017

If you are a consumer or patient please visit this version.

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children

  • INDICATIONS

    For the temporary relief of minor pain due to overexertion, bruises, minor injuries

  • WARNINGS

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

  • DOSAGE

    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. Do not exceed 12 tablets in 24 hours.

    Standard dosage:

    Adults and children 4 years and older:

    3 tablets per day, taking 1 tablet every 4 to 6 hours.

    Allow tablets to dissolve completely in the mouth, do not swallow

  • ACTIVE INGREDIENTS

    Active Ingredients: Each tablet contains: *Arnica montana, radix 6X, 12X, 30X, 200X, 75 mg each.

    *Natural ingredients

  • INACTIVE INGREDIENTS

    Inactive Ingredients: Lactose, Magnesium stearate

  • PURPOSE

    Relieves Pain due to:

    Overexertion

    • Bruises

    • Minor Injury

  • PRINCIPAL DISPLAY PANEL

    Traumed Tablet.jpg

  • INGREDIENTS AND APPEARANCE
    TRAUMED 
    arnica root tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-2301
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code Leafman
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-2301-2100 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/30/2014
    Labeler - MediNatura Inc. (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc.102783016manufacture(62795-2301)