Label: ARNICARE - arnica montana gel

  • NDC Code(s): 0220-9000-54, 0220-9000-59, 0220-9000-65, 0220-9000-66
  • Packager: Laboratoires Boiron
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

Drug Label Information

Updated 03/15

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 Item Code (Source) NDC:0220-9000
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0220-9000-66 1 in 1 PACKAGE
    1 120 g in 1 TUBE
    2 NDC:0220-9000-59 1 in 1 PACKAGE
    2 75 g in 1 TUBE
    3 NDC:0220-9000-54 1 in 1 PACKAGE
    3 45 g in 1 TUBE
    4 NDC:0220-9000-65 1 in 1 PACKAGE
    4 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 (282560473)
    Registrant - Boiron Inc. (014892269)
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