Label: SCIATISOOTHE- aconitum napellus, berberis vulgaris, chamomilla, colocynthis, magnesia phosphorica, rhus tox spray

  • 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 October 20, 2015

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

  • PRINCIPAL DISPLAY PANEL

    SciatiSoothe Label

  • HPUS Active Ingredients

    Each dose contains equal parts of: Aconitum napellus 6C, Berberis vulgaris 3X, Chamomilla 2X, Colocynthis 30C, Magnesia phosphorica 8X, Rhus tox 30C.

  • Uses

    *Homeopathic medicine for the temporary relief of sciatic pain and pressure. *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

  • Warnings

    If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children.

  • Directions

    Before initial use, depress pump 4-5 times or until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily, as needed, or until symptoms improve. Adults: Take 3 sprays. Children 2-12: Take 2 sprays.

  • Other Information

    Contains no artificial flavors or colors. No gluten added. Suitable for vegetarians. The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Tamper resistant for your protection. Use only if safety seal is intact.

  • INACTIVE INGREDIENT

    Citric acid, potassium sorbate, purified water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • PURPOSE

    Reduces occasional pain, pressure & inflammation from sciatica

  • INGREDIENTS AND APPEARANCE
    SCIATISOOTHE 
    aconitum napellus, berberis vulgaris, chamomilla, colocynthis, magnesia phosphorica, rhus tox spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-203
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]  in 59 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_C]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA2 [hp_X]  in 59 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_C]  in 59 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK3 [hp_X]  in 59 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP30 [hp_C]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-203-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/15/2016
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350manufacture(68703-203) , api manufacture(68703-203)