Label: COMBINATION REMEDY 37 - LOW BACK PAIN- arnica montana, bryonia alba, calcarea fluorica, cobaltum metallicum, gnaphalium polycephalum 6x, hypericum perforatum, rhus toxicodendron, ruta graveolens solution/ drops

  • 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 December 25, 2017

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  • WARNINGS

    Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

    If pregnant or breast-feeding, ask health professional before use.

    Do not use if tamper evident seal is missing or broken.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • ACTIVE INGREDIENT

    Agaricus Muscarius 6X

    Arnica Montana 1X

    Bryonia Alba 6X

    Calcarea Fluorica 6X

    Cobaltum Metallicum 6X

    Gnaphalium Polycephalum 6X

    Hypericum Perforatum 1X

    Rhus Toxicodendron 1X

    Ruta Graveolens 6X

  • PURPOSE

    Temporary relief from lower back pain, pain that starts in lower back and goes down in leg(s)..

  • INACTIVE INGREDIENT

    Purified Water

    Alcohol

  • DOSAGE & ADMINISTRATION

    Adults 18 years and older: Take 10-15 drops in half cup of water 3 times a day.

  • INDICATIONS & USAGE

    Temporary relief from lower back pain, pain that starts in lower back and goes down in leg(s).

  • PRINCIPAL DISPLAY PANEL

    lower back pain combo 37.jpg

  • INGREDIENTS AND APPEARANCE
    COMBINATION REMEDY 37 - LOW BACK PAIN 
    arnica montana, bryonia alba, calcarea fluorica, cobaltum metallicum, gnaphalium polycephalum 6x, hypericum perforatum, rhus toxicodendron, ruta graveolens solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69008-4037
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE6 [hp_X]  in 1 mL
    AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY6 [hp_X]  in 1 mL
    PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM6 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM1 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 1 mL
    COBALT (UNII: 3G0H8C9362) (COBALT - UNII:3G0H8C9362) COBALT6 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF1 [hp_X]  in 1 mL
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69008-4037-120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/15/2017
    Labeler - Warsan Homoeopathic Laboratories (645579772)
    Registrant - Warsan Homoeopathic Laboratories (645579772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Warsan Homoeopathic Laboratories645579772manufacture(69008-4037) , pack(69008-4037) , label(69008-4037)
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