Label: ARNICARE - arnica montana gel 

  • NDC Code(s): 0220-9000-54, 0220-9000-59, 0220-9000-65
  • Packager: Laboratoires Boiron
  • 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 12/13

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

  • ACTIVE INGREDIENT

    Arnica montana 1X

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  • INDICATIONS & USAGE

    For relief of muscle pain and stiffness due to minor injuries, overexertion and falls. Reduces pain and swelling as well as discoloration from bruising.

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  • DO NOT USE

    Do not use if tube seal is broken.

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  • DOSAGE & ADMINISTRATION

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

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  • INACTIVE INGREDIENT

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

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  • HOW SUPPLIED

    Tube 2.6, 1.5, or .5 OZ

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  • PURPOSE

    Arnica montana 1X trauma, muscle pain and stiffness, swelling from injuries, discoloration from bruising.

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  • STORAGE AND HANDLING

    Store at 68-77O F (20-25O C)

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  • QUESTIONS

    Questions, Comments?

    www.boironusa.com

    info@boironusa.com

    1-800-BOIRON-1 (1-800-264-7661)

    Boiron Information Center
    6 Campus Boulevard
    Newtown Square, PA 19073-3267

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  • STOP USE

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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  • WARNINGS

    For external use only
    Avoid contact with eyes and with open wounds.

    If swallowed, get medical help or contact a Poison Control Center immediately

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  • INGREDIENTS AND APPEARANCE
    ARNICARE 
    arnica montana gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0220-9000
    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]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    DIMETHICONE  
    WATER  
    SODIUM HYDROXIDE  
    CARBOMER HOMOPOLYMER TYPE C  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0220-9000-59 1 in 1 PACKAGE
    1 75 g in 1 TUBE
    2 NDC:0220-9000-54 1 in 1 PACKAGE
    2 45 g in 1 TUBE
    3 NDC:0220-9000-65 1 in 1 PACKAGE
    3 14 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/09/2007
    Labeler - Laboratoires Boiron (279527290)
    Registrant - Boiron Inc. (014892269)
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