Label: 365 EVERYDAY VALUE ARNICA - arnica montana gel 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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

  • WHEN USING

    Stop use and ask a doctor if condition persists for more than 3 days or worsens.

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  • STORAGE AND HANDLING

    Store at 68-77oF (20-25oC)

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  • INACTIVE INGREDIENT

    Alcohol, carbomer, dimethicone copolyol, purified water, sodium hydroxide

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  • QUESTIONS

    Whole Foods Market

    550 Bowie Street * Austin, TX 78703

    (c)2007 Whole Foods Market IP, LP

    Made in France

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  • ACTIVE INGREDIENT

    Arnica Montana 1X HPUS-7%  ---- Trauma, bruises, stiffness, muscle soreness

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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  • INDICATIONS & USAGE

    For relief of muscle aches and stiffness due to minor injuries, ushc as strains, falls and blows. Reduces pain, swelling and discoloration from bruises.

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  • DOSAGE & ADMINISTRATION

    Apply a thin layer of Arnica Gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed.

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  • WARNINGS

    For external use only

    Avoid contact with eyes and with open wounds. Do not use on broken skin.

    If swallowed, get medical help or contact a Poison Control Center right away.


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  • PRINCIPAL DISPLAY PANEL

    Arnica Gel Arnica Gel

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  • INGREDIENTS AND APPEARANCE
    365 EVERYDAY VALUE ARNICA 
    arnica montana gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42681-0512
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    CARBOMER HOMOPOLYMER TYPE C  
    DIMETHICONE  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42681-0512-5 1 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 09/01/2008
    Labeler - WFM Private Label, LP (196175616)
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