Label: ARNICARE PROCEDURE RECOVERY- arnica montana kit

  • NDC Code(s): 0220-0508-41, 0220-9050-75
  • 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 January 5, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient** (in each pellet)

    Arnica montana 12C (0.443 mg)

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

  • PURPOSE

    Purpose*

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

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves muscle pain and stiffness due to:

    • minor injuries
    • overexertion
    • falls
    • minor procedures

    reduces symptoms of bruising such as:

    • pain
    • swelling
    • discoloration
  • STOP USE

    Stop use and ask a doctor if symptoms persist for more than 3 days or get worse, new symptoms occur, or redness or swelling is present. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    Before procedure: Dissolve 5 pellets under the tongue 3 times a day for 2 days.

    After procedure: Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved.

  • INACTIVE INGREDIENT

    lactose, sucrose

  • QUESTIONS

    Questions, Comments?
    www.boironusa.com
    info@boironusa.com

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

    Newtown Square, PA 19073-3267

  • WARNINGS

  • SPL UNCLASSIFIED SECTION

    do not use if pellet dispenser seal is broken

    3 tubes of Boiron Arnica montana 12C** HPUS

    Provides approximately 15 days of treatment

    Made in France

    Boiron Arnica montana pellets reduce bruising, swelling, and pain used before and after your procedure.

    Non-habit forming

    Non-drowsy

    No known drug interactions

    post-operative care*

    Dissolve 5 pellets under the tongue 3 times a day for 2 days.

    Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved.

    Turn tube upside down. Twist until 5 pellets are dispensed. Remove cap and pour pellets under the tongue.

    *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.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ARNICARE PROCEDURE RECOVERY 
    arnica montana kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9050
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9050-751 in 1 PACKAGE11/01/2007
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 TUBE
    Part 1 of 1
    ARNICA 
    arnica montana pellet
    Product Information
    Item Code (Source)NDC:0220-0508
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (Pellet) Size4mm
    FlavorImprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-0508-4180 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2007
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9050)