Label: ARNICA PLUS- arnica montana, hamamelis virginiana, rhus tox 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 Tox 6X, 12X.

  • INDICATIONS:

    May temporarily relieve 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.

  • 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.

    Do not use if safety seal is broken or missing.

  • 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.

  • DIRECTIONS:

    Apply at least 3 times daily over the affected area.

  • INDICATIONS:

    May temporarily relieve 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.

  • INACTIVE INGREDIENTS:

    Purified Water, Grapeseed (Seed) Carrier Oil, Whey Protein Concentrate, Lecithin (Soy) (Liquid)Sodium Hydroxide (Solution), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), Arnica (flower), Aloe Barbadensis Leaf Juice, White Willow (bark), Witch Hazel (bark), Ascorbic Acid, Devil’s Claw (root), Polysorbate 20, Tocopherol [Vitamin E Oil], Peppermint (leaf), Edetate Disodium (EDTA), Natural plant extract (Origanox WS), Potassium Sorbate.

  • QUESTIONS:

    Dist. By Peaceful Mountain, Inc.

    Woodbine, IA 51579

    888-303-3388

    www.peacefulmountain.com

  • PACKAGE LABEL DISPLAY:

    arnica

    plus®

    peaceful mountain

    THE HEIGHT OF HEALTH

    homeopathic gel

    formulated in

    boulder, co

    Net wt. 2 oz. (57g)

    Arnica Plus

  • INGREDIENTS AND APPEARANCE
    ARNICA PLUS 
    arnica montana, hamamelis virginiana, rhus tox gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0060
    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
    WATER (UNII: 059QF0KO0R)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    WHEY (UNII: 8617Z5FMF6)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OREGANO (UNII: 0E5AT8T16U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0060-157 g in 1 TUBE; Type 0: Not a Combination Product05/09/201608/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2016
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0060) , api manufacture(43846-0060) , label(43846-0060) , pack(43846-0060)
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