Label: ARNICA POWER- arnica montana liquid

  • NDC Code(s): 61096-1032-1
  • Packager: Eight and Company L.L.C
  • Category: HUMAN OTC DRUG LABEL

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 14, 2023

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  • ACTIVE INGREDIENTS:

    Arnica Montana 3X, 4X, 6X.

  • PURPOSE:

    Temporarily relieves symptoms associated with overexertion or trauma, such as:

    • muscle aches
    • stiffness
    • swelling from injuries
    • bruising

  • WARNINGS:

    If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    Adults and children over 12: 2 sprays into the mouth 3 times per day. For additional symptom relief spray directly  on the affected area and massage gently into the skin. Repeat 3 times a day or as needed.

    Children Under 12: consult a healthcare professional.

  • OTHER INFORMATION:

    Do not use if the transparent seal around spray bottle is broken or missing.

  • INDICATIONS:

    Temporarily relieves symptoms associated with overexertion or trauma, such as:

    • muscle aches
    • stiffness
    • swelling from injuries
    • bruising

    ° natural

    ° gluten & lactose free

    ° no artificial flavors or colors

    ° vegan

    ° no known negative side effects

    ° no known negative drug interactions

  • INACTIVE INGREDIENTS:

    Non-GMO G=glycerin, organic alcohol 20% v/v, purified water.

  • QUESTIONS:

    Mfd. for Eight and Company L.L.C.

    Gaithersburg, MD 20878 1.800.377.5787

    www.sprayology.com

  • PACKAGE LABEL DISPLAY:

    Sprayology

    Arnica Power3

    RELIEVES MUSCLE PAIN + BRUISING

    HOMEOPATHIC ORAL SPRAY

    1.38 fl. oz (41 ml)

    Arnica Power3 lbl

    Arnica Power3 ctn

  • INGREDIENTS AND APPEARANCE
    ARNICA POWER 
    arnica montana liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61096-1032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE3 [hp_X]  in 41 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61096-1032-11 in 1 CARTON03/08/2019
    141 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/08/2019
    Labeler - Eight and Company L.L.C (927364120)
    Registrant - Apotheca Company (844330915)
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