Label: ARNICARE- arnica montana cream

  • NDC Code(s): 0220-9021-60, 0220-9021-63, 0220-9021-68, 0220-9021-82
  • Packager: Laboratoires Boiron
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated August 19, 2024

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  • ACTIVE INGREDIENT

    Active ingredient**

    Arnica montana 1X HPUS 7%

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Purpose*

    Relieves minor muscle pain & stiffness, swelling from injuries, discoloration from bruises

  • INDICATIONS & USAGE

    temporarily relieves minor muscle pain and stiffness due to:

    minor injuries

    overexertion

    falls

    reduces symptoms of bruising such as:

    pain

    swelling

    discoloration

  • WARNINGS

    For external use only.

  • DO NOT USE

    Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.

  • STOP USE

    Stop use and ask a doctor if

    • condition persists for more than 3 days or worsens
    • symptoms clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • Adults and children 1 year of age and older: Apply a thin layer of Arnicare cream to affected area and massage gently as soon as possible after minor injury up to 3 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Cream.
    • Children under 1 year of age: Not recommended.
  • INACTIVE INGREDIENT

    arachidyl alcohol, arachidyl glucoside, behenyl alcohol, Butyrospermum parkii (Shea) butter, coconut oil, glycerin, lactobacillus ferment, purified water, xanthan gum

  • QUESTIONS

    Arnicare.com

    BoironUSA.com

    Info@Boiron.com

    1-800-BOIRON-1

    (1-800-264-7661)

    Distributed by Boiron Inc.

    Newtown Square, PA 19073

  • SPL UNCLASSIFIED SECTION

    do not use if glued carton end flaps are open or if the tube seal is broken

    dispose of 1 year after opening

    0.5 oz (14 g)

    1.4 oz (40 g)

    2.5 oz (70 g)

    4.2 oz (120 g)

    Pain Relief*

    Muscle Pain & Stiffness Swelling from Injuries Bruises*

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

    ɨ Homeopathic mother tincture made from Arnica montana fresh whole plant.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ARNICARE 
    arnica montana cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9021-6040 g in 1 TUBE; Type 0: Not a Combination Product03/01/2007
    2NDC:0220-9021-6370 g in 1 TUBE; Type 0: Not a Combination Product03/01/2007
    3NDC:0220-9021-821 in 1 BOX06/01/2018
    3120 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0220-9021-681 in 1 BOX02/29/2016
    414 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2007
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9021)
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