Label: ARNICARE BRUISE- arnica montana tablet

  • 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 October 4, 2023

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  • ACTIVE INGREDIENT

    Active ingredient** (in each tablet)

    Arnica montana 9C HPUS (2.5 mg)

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

  • PURPOSE

    Purpose*

    Arnica montana 9C HPUS (2.5 mg) ... Relieves discoloration, pain, and swelling associated with bruising

  • INDICATIONS & USAGE

    Uses*

    reduces symptoms of bruising such as: discoloration, pain, swelling

  • WARNINGS

  • ASK DOCTOR

    Ask a doctor before use if

    • bruising limits the range of motion of your eyes, limbs, head
    • pain is severe
    • bruising is frequent.
  • STOP USE

    Stop use and ask a doctor if symptoms persist for more than 7 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health profession before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 6 years of age and older - As soon as bruising occurs, dissolve 2 tablets in the mouth and repeat every hour for 2 more hours. Then, dissolve 2 tablets in the mouth every 6 hours until bruising has faded.

    Children 2 to 5 years of age - Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.

    Children under 2 years of age - Ask a doctor.

  • SPL UNCLASSIFIED SECTION

    • do not use if glued carton end flaps are open or if the blister seal is broken
    • store below 86° F (30° C)

    60 meltaway tablets

    Bruise relief*

    Discoloration, Pain, Swelling*

    No Known Drug Interactions

    Non-Drowsy

    Gentle on the stomach

    Convenient & Painless

    Meltaway Tablets Require No Food or Water

    *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.

  • INACTIVE INGREDIENT

    croscarmellose sodium, lactose, magnesium stearate

  • QUESTIONS

    Arnicare.com

    BoironUSA.com

    Info@Boiron.com

    1-800-BOIRON-1

    (1-800-264-7661)

    Made in France

    Distributed by Boiron Inc.

    Newtown Square, PA 19073

  • PRINCIPAL DISPLAY PANEL

    labelLabel

  • INGREDIENTS AND APPEARANCE
    ARNICARE BRUISE 
    arnica montana tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9083
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA9 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (Boiron) Size9mm
    FlavorImprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9083-0460 in 1 BLISTER PACK; Type 0: Not a Combination Product01/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/18/2022
    Labeler - Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9083)
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