Label: MUSCLE RESCUE- arnica montana, rhus toxicodendron, phytolacca decandra, pulsatilla, ruta graveolens gel

  • Category: HUMAN PRESCRIPTION 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 August 12, 2013

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

  • ACTIVE INGREDIENTS:

    Arnica Montana 3X, Rhus Toxicodendron 3X, Phytolacca Decandra 12X, Pulsatilla 12X, Ruta Graveolens 12X

  • INDICATIONS:

    For temporary relief of minor symptoms of muscle aches, pains from overexertion, and injury.

  • 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 affected area. Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENTS:

    Aloe Vera Concentrate, Arnica Montana, Carbomer, Symphytum Officinale, Edetate Disodium, Natural Plant Extract, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Potassium Sorbate, Purified Water, Sodium Hydroxide, Vitamin c, Vitamin E Oil, Salix Alba, 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:

    For temporary relief of minor symptoms of muscle aches, pains from overexertion, and injury.

  • QUESTIONS:

    Dist. by Peaceful Mountain, Inc.

    Woodbine, IA 51579

    888-303-3388

    www.peacefulmountain.com

  • PACKAGE DISPLAY LABEL:

    Muscle Rescue

    Peaceful Mountain

    homeopathic gel

    Net wt. 3.7 oz. (105 g)

    image description

  • INGREDIENTS AND APPEARANCE
    MUSCLE RESCUE 
    arnica montana, rhus toxicodendron, phytolacca decandra, pulsatilla, ruta graveolens gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43846-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF3 [hp_X]  in 1 g
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT12 [hp_X]  in 1 g
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 1 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP12 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OREGANO (UNII: 0E5AT8T16U)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    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:43846-0004-1105 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/12/2013
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0004) , api manufacture(43846-0004) , label(43846-0004) , pack(43846-0004)