Label: ARNICA PLUS- arnica montana, hamamelis virginiana bark and toxicodendron pubescens leaf gel 

  • Label RSS
  • NDC Code(s): 43846-0026-1
  • Packager: Peaceful Mountain, 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 6X,12X, Hamamelis Virginiana 6X,12X, Rhus Toxicodendron 6X,12X.

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  • INDICATIONS

    For temporary relief of minor symptoms of sore, overexerted muscles.

    These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug

    Administration.

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  • WARNINGS

    For external use only. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product, do not get into eyes. Stop use and ask a doctor if conditions worsens, symptoms last more than 7 days.

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  • DIRECTIONS

    Apply at least 3 times daily over the affected area.

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  • INACTIVE INGREDIENTS

    Aloe Vera 10X Concentrate, Arnica (Flower) Arnica Montana, Carbomer (ULTREZ 21), Harpagophytum Procumbens (root), Edetate Disodium (EDTA), Origanox WS, PEG-33, PEG-8 Dimethicone, PEG-14 (Silsense, Copolyol 1 Silicone), Mentha Piperita (leaf), Phenoxyethanol and Caprylyl Glycol, Sorbic Acid (Optiphen Plus), Potassium Sorbate, Purified Water, Sodium Hydroxide (Solution), Ascorbic Acid, Vitamin E Oil (derived from Soy Bean), Salix Alba (bark), Hamamelis Virginiana.

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  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away. When using this product, do not get into eyes.

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  • INDICATIONSAND USAGE

    For the temporary relief of minor symptoms of sore, overexerted muscles.

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  • QUESTIONS

    Dist. by Peaceful Mountain, Inc.

    Woodbine, IA 51579

    888-303-3388

    www.peacefulmountain.com

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  • PRINCIPAL DISPLAY PANEL

    peaceful mountain

    THE HEIGHT OF HEALTH

    arnica plus

    homeopathic gel

    paraben free

    organic and

    wild crafted herbs

    formulated in boulder, co

    Net wt. 4 lbs. (64 oz.) (1.8 kg)

    Arnica Plus

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  • INGREDIENTS AND APPEARANCE
    ARNICA PLUS 
    arnica montana, hamamelis virginiana, rhus toxicodendron gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:43846-0026
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 6 [hp_X]  in 1 g
    HAMAMELIS VIRGINIANA BARK (HAMAMELIS VIRGINIANA BARK) HAMAMELIS VIRGINIANA BARK 6 [hp_X]  in 1 g
    TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    ARNICA MONTANA FLOWER  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)  
    HARPAGOPHYTUM PROCUMBENS ROOT  
    EDETATE DISODIUM  
    ORIGANUM VULGARE SUBSP. HIRTUM FLOWER  
    PEG-8 DIMETHICONE  
    POLYETHYLENE GLYCOL 1500  
    POLYETHYLENE GLYCOL 700  
    MENTHA PIPERITA LEAF  
    PHENOXYETHANOL  
    CAPRYLYL GLYCOL  
    SORBIC ACID  
    POTASSIUM SORBATE  
    WATER  
    SODIUM HYDROXIDE  
    ASCORBIC ACID  
    ALPHA-TOCOPHEROL  
    SALIX ALBA BARK  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43846-0026-1 1814 g in 1 JUG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/11/2012
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43846-0026)
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