Label: ARNICA- arnica montana root liquid 

  • NDC Code(s): 43857-0070-1
  • Packager: BioActive Nutritional, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/12

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

  • ACTIVE INGREDIENTS

    Arnica Montana 3X

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  • INDICATIONS

    For temporary relief of conditions caused by injuries, contusions, blows and falls.

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  • WARNINGS

    If pregnant or breast-feeding, 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. Do not use if tamper evident seal is broken or missing. Store in cool, dry place.

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  • DIRECTIONS

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

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  • INACTIVE INGREDIENTS

    Demineralized water, 25% Ethanol.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INDICATIONS AND USAGE

    For temporary relief of conditions caused by injuries, contusions, blows and falls.

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  • QUESTIONS

    Distributed by:

    BIOACTIVE NUTRITIONAL

    Melbourne, FL 32935

    For Nutritional Information write:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

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  • PRINCIPAL DISPLAY PANEL

    BioActive Homeopathic

    ARNICA 3X

    1 FL OZ (30 ml)

    Arnica 3X

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  • INGREDIENTS AND APPEARANCE
    ARNICA 
    arnica montana liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:43857-0070
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT 3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43857-0070-1 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/08/2012
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43857-0070)
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