Label: ARNICA 12C- arnica montana pellet

  • 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 September 13, 2023

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  • ACTIVE INGREDIENT

    Homeopathic dilution of HPUS Arnica Montana 12c

  • PURPOSE

    Pain from muscle soreness, stiffness, swelling - Bruises*

  • USE

    Condition listed above or as directed by a physician.

  • WARNINGS

    Stop use and ask a physician if symptoms persist for more than 3 days or worsen.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DO NOT USE

    Do not use if pellet-dispenser seal is broken.

  • DIRECTIONS

    (adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

  • OTHER INFORMATION

    Store at room temperature.

  • INACTIVE INGREDIENT

    Sucrose.

  • QUESTIONS?

    www.ollois.com * info@ollois.com* Call 1-855-OLLOMED (Mon-Fri 8am-5pm PST). Made in FRANCE. Not reviewed by the FDA and not guaranteed to be effective. This Homeopathic dilution may not be suseptible to scientific measurement.

  • PRINCIPAL DISPLAY PANEL

    ARNICA MONTANA 12c

  • INGREDIENTS AND APPEARANCE
    ARNICA 12C 
    arnica montana pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76472-1127
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA12 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76472-1127-180 in 1 CYLINDER; Type 0: Not a Combination Product11/30/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/30/2011
    Labeler - SEVENE USA (969332936)
    Registrant - SEVENE USA (969332936)
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