Label: ARNICA- arnica montana tablet

  • NDC Code(s): 0360-0041-03
  • Packager: STANDARD HOMEOPATHIC COMPANY
  • 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 December 26, 2018

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

  • SPL UNCLASSIFIED SECTION

    Made according to the
    Homeopathic Pharmacopoeia
    of the United States since 1903.

  • Warnings

    Do not use if cap band is missing or broken.

    If you are pregnant or nursing, consult a licensed health
    care professional before using this product.

    If symptoms persist for 7 days or worsen,
    contact a licensed practitioner.

    Keep this and all medicines out of the reach of children.

    To be used according to label indications and/or
    standard homeopathic indications.

  • QUESTIONS

    Standard Homeopathic Company
    Los Angeles, CA 90061
    Questions? 800-624-9659

  • Directions

    Adults: Dissolve 4 tablets under tongue 4 times a day.
    Children: Consult a healthcare professional.

  • INACTIVE INGREDIENT

    In a base of Acacia Gum and Lactose N.F.

  • ACTIVE INGREDIENT

    ARNICA MONTANA 30X

  • INDICATIONS & USAGE

    BRUISES OR MUSCLE SORENESS

  • Principal Display Panel -- 250 Tablet Bottle Label

    Standard

    Homeopathic

    Made in the USA Since 1903

    NDC # 0360-0041-03

    Homeopathic Medicine

    ARNICA MONTANA.

    30X

    BRUISES OR MUSCLE

    SORENESS*


    *Claims based on traditional homeopathic

    practice, not accepted medical evidence.

    Not FDA evaluated.

    250 TABLETS

    label

  • INGREDIENTS AND APPEARANCE
    ARNICA 
    arnica montana tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0360-0041
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0360-0041-031 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/17/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/17/1997
    Labeler - STANDARD HOMEOPATHIC COMPANY (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    STANDARD HOMEOPATHIC COMPANY008316655manufacture(0360-0041) , pack(0360-0041) , label(0360-0041)