Label: ARNICA MONTANA, RADIX- mountain arnica granule

  • 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 September 22, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    ARNICA MONTANA (Mountain arnica) 12CH GR

    ARNICA MONTANA (Mountain arnica) 15CH GR

    ARNICA MONTANA (Mountain arnica) 200CH GR

    ARNICA MONTANA (Mountain arnica) 200K GR

    ARNICA MONTANA (Mountain arnica) 30CH GR

    ARNICA MONTANA (Mountain arnica) 30K GR

    ARNICA MONTANA (Mountain arnica) 4CH GR

    ARNICA MONTANA (Mountain arnica) 5CH GR

    ARNICA MONTANA (Mountain arnica) 6CH GR

    ARNICA MONTANA (Mountain arnica) 7CH GR

    ARNICA MONTANA (Mountain arnica) 9CH GR

    ARNICA MONTANA (Mountain arnica) CMK GR

    ARNICA MONTANA (Mountain arnica) LMK GR

    ARNICA MONTANA (Mountain arnica) MK GR

    ARNICA MONTANA (Mountain arnica) XMK GR

  • PURPOSE

    Uses

    Helps to maintain musculoskeletal health

  • WARNINGS

    Warning

    Stop use and ask a doctor if symptoms persist or worsen.

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

    Keep out of reach of children.

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

  • 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.

  • OVERDOSAGE

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Lactose (milk), sucrose

  • DOSAGE & ADMINISTRATION

    Directions

    Adults: Take 5 granules 3 times daily or as recommended by your healthcare practitioner.
    Children: Take under the direction of your healthcare practitioner.

  • QUESTIONS

    QUESTIONS? 1-888-737-6925.

  • INDICATIONS & USAGE

    Uses

    Helps to maintain musculoskeletal health

    Directions

    Adults: Take 5 granules 3 times daily or as recommended by your healthcare practitioner.
    Children: Take under the direction of your healthcare practitioner.

  • PRINCIPAL DISPLAY PANEL

    62106-7385

    UNDA

    Do not use if label perforation is broken.

    Homeopathic Remedy

    NDC : 62106-7385-4

    ARNICA MONTANA, RADIX

    Mountain arnica

    140 granules

    Helps to maintain musculoskeletal health

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA, RADIX 
    mountain arnica granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-7385
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-7385-410 in 1 CARTON01/26/201510/31/2024
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/26/201510/31/2024
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-7385)
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