Label: BACK AND NECK RESCUE- hypericum perforatum, phytolacca decandra, guaiacum, ledum palustre, conium maculatum lotion

  • 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 September 19, 2012

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

  • ACTIVE INGREDIENTS

    Hypericum Perforatum 3X, Phytolacca Decandra 3X, Guaiacum 6X, Ledum Palustre 6X, Conium Maculatum 30X.

  • INDICATIONS

    For the temporary relief of minor symptoms of back and neck discomfort.

  • 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 conditions worsen, symptoms last more than 7 days.

  • DIRECTIONS

    Apply at least 3 times daily over the affected area. Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENTS

    Aloe Vera 10X Concentrate, Arnica Montana, Carbomer, Comfrey (leaf), Edetate Disodium (EDTA), Lavandula Spp., Natural plant extract, PEG-33, PEG-8 Dimethicone and PEG-14. Phenoxyethanol, Caprylyl Glycol and Sorbic Acid, Potassium Sorbate, Purified Water, Sodium Hydroxide Solution, Hypericum Perforatum, Ascorbic Acid, Vitamin E Oil, Salix Alba, Achillea Millefolium.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS AND USAGE

    For the temporary relief of minor symptoms of back and neck discomfort.

  • QUESTIONS

    Dist. by Peaceful Mountain, Inc.

    Woodbine, IA 51579 888-303-3388

    www.peacefulmountain.com

  • PRINCIPAL DISPLAY PANEL

    peaceful mountain

    THE HEIGHT OF HEALTH

    back and neck rescue

    homeopathic gel

    formulated in boulder, co

    Net wt. 0.25 oz (7 g)

    image description

  • INGREDIENTS AND APPEARANCE
    BACK AND NECK RESCUE 
    hypericum perforatum, phytolacca decandra, guaiacum, ledum palustre, conium maculatum lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43846-0015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 1 g
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 g
    GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6) GUAIACUM OFFICINALE RESIN6 [hp_X]  in 1 g
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG6 [hp_X]  in 1 g
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP30 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    OREGANO FLOWERING TOP (UNII: 7K91ZBK8GJ)  
    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)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0015-17 g in 1 PACKET
    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(43846-0015)