Label: ARNICA MONTANA 30X BONUS PACK- 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 April 3, 2024

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  • ACTIVE INGREDIENT

    Active ingredient** (in each pellet)

    Arnica montana 30X HPUS (0.44 mg)

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

  • PURPOSE

    Purpose*

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

  • ASK DOCTOR

    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 signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • INACTIVE INGREDIENT

    lactose, sucrose

  • SPL UNCLASSIFIED SECTION

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

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

    3 Tubes

    Approx. 80 pellets each

    Total 240 pellets

    16 Doses per tube

    Pain relief*

    Muscle Pain & Stiffness Swelling from injuries Bruises*

    No Know Drug Interactions

    Plant-Powered Relief

    *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.

  • QUESTIONS

    Arnicare.com

    BoironUSA.com

    Info@Boiron.com

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

    Distributed by Boiron, Inc.

    Newtown Square, PA 19073

    Made in France

  • PRINCIPAL DISPLAY PANEL

    labellabelimagebox

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA 30X BONUS PACK 
    arnica montana pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9053
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]
    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:0220-9053-433 in 1 PACKAGE07/01/2017
    180 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2017
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9053)
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