Label: ARNICA PLUS- arnica montana, hamamelis virginiana, rhus toxicodendron, gel

  • 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 29, 2016

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  • ACTIVE INGREDIENTS

    Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Toxicodendron 6X, 12X,

  • PURPOSE

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

  • WARNINGS

    For external use only.

    If pregnant or breast-feeding, 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 condition worsens, symptoms last more than 7 days.

  • DIRECTIONS

    Apply at least 3 times daily over the affected area.

  • INACTIVE INGREDIENTS

    Aloe Vera 10X Concentrate, Arnica (flower) Arnica Montana, Carbomer (Ultrez21), Devil's Claw (root) Harpagophytum Procumbens, Edetat Disodium (EDTA), Natural Plant Extract (Origanox WS), PEG-33, PEG-8 Dimethicone, PEG-14, Peppermint (leaf) Mentha Piperita, Phenoxyethanol and Caprylyl Glycol and Sorbic Acid (Optiphen Plus), Potassium Sorbate, Purified Water, Sodium Hydroxide Solution, Vitamin C (Powder) Ascorbic Acid, Vitamin E Oil (derived from Soy Bean), White Willow (bark) Salix Alba, Witch Hazel (bark) Hamamelis Virginiana.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS AND USAGE

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

  • QUESTIONS

    Dist. by Peaceful Mountain, Inc.

    Woodbine, IA 51579 888-303-3388

    www.peacefulmountain.com

  • PACKAGE LABEL DISPLAY:

    peaceful mountain

    THE HEIGHT OF HEALTH

    arnica plus

    homeopathic gel

    formulated in boulder, co

    Net wt. 0.25 oz. (7 g)

    Arnica Plus

  • INGREDIENTS AND APPEARANCE
    ARNICA PLUS 
    arnica montana, hamamelis virginiana, rhus toxicodendron, gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 1 g
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK6 [hp_X]  in 1 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ORIGANUM VULGARE SUBSP. HIRTUM FLOWER (UNII: 3799SP11NY)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    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)  
    HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0016-17 g in 1 PACKET; Type 0: Not a Combination Product09/19/201208/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/19/2012
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0016) , api manufacture(43846-0016) , label(43846-0016) , pack(43846-0016)
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