Label: SCIATIC RESCUE- phytolacca decandra, gnaphalium polycephalum, colocynthis, gelsemium sempervirens 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 August 24, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: Phytolacca Decandra 1X, Gnaphalium Polycephalum 3X, Colocynthis 6X, Gelsemium Sempervirens 6X.

  • PURPOSE

    INDICATIONS: For temporary relief of sharp pain along the sciatic nerve, lower back and down the back of the legs.**

    **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • WARNINGS

    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 Posion 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 that 7 days.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Massage generously as needed.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Aloe Vera Concentrate, Arnica Flower, Edetate Disodium, Jamica Dogwood Bark, Lavender Buds, Natural Plant Extract, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Poke Root, Potassium Sorbate, Purified Water, Sodium Hydroxide, St. John's Wort Aerial Parts, Vitamin C, Vitamin E (soy), White Willow Bark, Yarrow Flower.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    INDICATIONS: For temporary relief of sharp pain along the sciatic nerve, lower back and down the back of the legs.**

    **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • QUESTIONS

    Dist. by Peacaful Mountain, Inc.

    Woodbine, IA 51579

    888-303-3388

    www.peacefulmountain.com

    patent pending

    uncented

    Non-greasy

    no petroleum

    no animal testing

  • PRINCIPAL DISPLAY PANEL

    peaceful mountain

    The Height of Health

    sciatic rescue

    homeopathic gel

    paraben-free

    organic and

    wild-crafted herbs

    formulated in boulder, co

    Net wt. 4lbs. (64 oz.) (1.8 kg)

    sciatic rescue

  • INGREDIENTS AND APPEARANCE
    SCIATIC RESCUE 
    phytolacca decandra, gnaphalium polycephalum, colocynthis, gelsemium sempervirens gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT1 [hp_X]  in 1 g
    PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM3 [hp_X]  in 1 g
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]  in 1 g
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PISCIDIA PISCIPULA ROOT BARK (UNII: 58JV0P12FY)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    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)  
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    ORIGANUM VULGARE SUBSP. HIRTUM FLOWER (UNII: 3799SP11NY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0014-11814 g in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/24/2012
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0014)
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