Label: ARNICARE - arnica montana cream 

  • NDC Code(s): 0220-9021-60, 0220-9021-63
  • 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 01/14

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

  • ACTIVE INGREDIENT

    Arnica Montana 1X

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  • INDICATIONS & USAGE

    Temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls. Reduces pain, swelling and discoloration from bruises.

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  • DO NOT USE

    Do not use if glued carton en flaps are open or if the tube seal is broken.

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  • DOSAGE & ADMINISTRATION

    Apply a thin layer of Arnicare Cream to affected area and massage after minor injury. Repeat 3 times a day or as needed.

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  • INACTIVE INGREDIENT

    Alcohol, Caprylyl glycol, carbomer, cetyl palmitate, EDTA disodium, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

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  • HOW SUPPLIED

    Tube 2.5 OZ (70 G)
    or
    Tube 1.33 OZ (40G)

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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.arnicare.com
    www.boironusa.com

    info@boironusa.com

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

    Distributed by Boiron Inc.
    6 Campus Boulevard
    Newtown Square, PA 19073-3267

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  • STOP USE

    Stop use and ask doctor 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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  • DRUG INTERACTIONS

    Unscented - Paraben-Free - Great for massage - Works naturally with your body

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  • WARNINGS

    For external use only
    Avoid contact with eyes.

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

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  • INGREDIENTS AND APPEARANCE
    ARNICARE 
    arnica montana cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0220-9021
    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
    CAPRYLYL GLYCOL  
    CARBOMER 934  
    CETYL PALMITATE  
    EDETATE DISODIUM  
    WATER  
    SODIUM HYDROXIDE  
    SORBIC ACID  
    1,2-HEXANEDIOL  
    GLYCERIN  
    HYDROGENATED PALM KERNEL OIL  
    PEGOXOL 7 STEARATE  
    ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0220-9021-60 40 g in 1 TUBE
    2 NDC:0220-9021-63 70 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/15/2007
    Labeler - Laboratoires Boiron (279527290)
    Registrant - Boiron Inc. (014892269)
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