Label: ARNICA RELIEF- arnica montana 10x, 30x, 100x 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 November 5, 2013

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  • ACTIVE INGREDIENTS HPUS

    Arnica montana 10X, 30X, 100X

  • REFERENCES

    Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

  • PURPOSE

    Pain relief. Helps relieve symptoms due to minor bruises, strains and sprains

  • USES

    This Homeopathic product of natural source helps relieve symptoms due to minor bruises, strains and sprains.

  • WARNINGS

  • ASK DOCTOR

    If symptoms persist or worsen, discontinue use and contact a health professional.

  • PREGNANCY OR BREAST FEEDING

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medications out of reach of children.

  • DIRECTIONS

    Adults: Allow 3 pellets to dissolve under the tongue three times a day, or as directed by a health professional.

    For adult use only. Do not exceed recommended dosage.

  • OTHER INFORMATION

    Do not use if cap seal is broken.

    Homeolab USA Inc., 3025 De L'Assomption Blvd., Montreal, QC H1N 2H2  Canada

    PRODUCT OF CANADA

  • CARTON

    IMAGE OF CARTONIMAGE OF LABEL

  • INGREDIENTS AND APPEARANCE
    ARNICA RELIEF 
    arnica montana 10x, 30x, 100x pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA10 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9058-180 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2013
    Labeler - HOMEOLAB USA INC. (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC.202032533manufacture(60512-9058)
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