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

  • NDC Code(s): 43846-0026-1
  • Packager: Peaceful Mountain, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 Item Code (Source) NDC:43846-0026
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 6 [hp_X]  in 1 g
    HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY) (HAMAMELIS VIRGINIANA BARK - UNII:IH3063S9MY) HAMAMELIS VIRGINIANA BARK 6 [hp_X]  in 1 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ORIGANUM VULGARE SUBSP. HIRTUM FLOWER (UNII: 3799SP11NY)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    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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