Label: ARNICA MONTANA- arnica montana pellet

  • 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 May 21, 2024

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

  • ACTIVE INGREDIENT

    Active ingredient** (in each pellet)

    Arnica montana 200CK HPUS (0.44 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 200CK HPUS (0.44 mg) ... Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves minor muscle pain and stiffness due to:

    • minor injuries
    • overexertion
    • falls

    reduces symptoms of bruising such as:

    • pain
    • swelling
    • discoloration
  • WARNINGS

  • STOP USE

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

    Tube: Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

  • PREGNANCY OR BREAST FEEDING

    Box: If pregnant or breast-feeding, ask a health professional before use.

    Tube: If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

    Tube: Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    Box:

    Do not use if glued carton end flaps are open or if pellet dispenser seal is broken.

    3 Tubes

    Approx 80 pellets each

    Total 240 pellets
    16 Doses per tube

    No known drug interactions

    Plant-Powered Relief

    Pain Relief*

    Muscle Pain & Stiffness Swelling from Injuries Bruises*

    Meltaway Pellets
    How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed. Remove cap and pour pellets under the tongue

    Tube:

    Do not use if pellet dispenser seal is broken.
    Contains approx 80 pellets.
    How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to 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.

  • INACTIVE INGREDIENT

    lactose, sucrose

  • DOSAGE & ADMINISTRATION

    Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

  • QUESTIONS

    Arnicare.com

    BoironUSA.com

    Info@Boiron.com

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

  • PRINCIPAL DISPLAY PANEL

    labellabellabel

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA 
    arnica montana pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-0502
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA200 [kp_C]  in 200 [kp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-0502-41200 [kp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    2NDC:0220-0502-433 in 1 BOX05/20/2024
    2200 [kp_C] in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/1983
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-0502)