Label: HOMEOPATHIC ARNICA DROPS- arnica montana 6x lozenge

  • NDC Code(s): 57556-001-01
  • Packager: Historical Remedies LLP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated November 1, 2023

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  • Active ingredient

    Natural Homeopathic Arnica 6X, Arnica 12X, Arnica 30X

  • PURPOSE

  • Indications

    For temporary relief of aching, strained muscles, bumps and bruises. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • Warning

    If symptoms persist more than 7 days or worsen, consult a physician.

    Keep out of children’s reach.In case of overdose, get medical help or contact a poison control center right away.

    If pregnant or breast-feeding, ask a doctor before use.
    Do not use if shrink wrap is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions 

    Adults & children over 8: dissolve one lozenge in mouth. Repeat every half hour as needed.

  • Inactive Ingredients:

    Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, tangerine flavor.

    4 calories per lozenge. 1 gram sugar per lozenge.
    No gluten added. Vegan.

  • Product label

    Label

  • INGREDIENTS AND APPEARANCE
    HOMEOPATHIC ARNICA DROPS 
    arnica montana 6x lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57556-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    LEMON OIL (UNII: I9GRO824LL)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize14mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57556-001-0130 in 1 BOX; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2020
    Labeler - Historical Remedies LLP (627758634)
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