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

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

    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 Item Code (Source) NDC:0220-9021
    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
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    ALCOHOL (UNII: 3K9958V90M)  
    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 (282560473)
    Registrant - Boiron Inc. (014892269)
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