Label: ARNICA SCORODITE- colloidal silicon dioxide, arnica montana, ostrea edulis shell, levisticum officinale root, sodium carbonate, orchis mascula tuber, fluorapatite, ferrous arsenate and bos taurus cerebellum liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/14

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  • INDICATIONS & USAGE

    Directions: FOR ORAL USE.

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  • DOSAGE & ADMINISTRATION

    Take the contents of one ampule
    under the tongue and hold for
    30 seconds, then swallow.

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  • ACTIVE INGREDIENT


    Active Ingredients: Amethyst 6X, Arnica e pl. tota 6X, Conchae 6X, Levisticum e rad. 6X, Natrium carb. 6X, Orchis e tub. decoct. 6X, Apatite 7X, Scorodite 7X, Cerebellum 8X

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Salt, Lactose

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  • PURPOSE

    Use: Temporary relief of headache.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

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  • WARNINGS

    Warnings: Do not use if allergic to any ingredient. Consult a doctor before use if lactose intolerant. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Natural ingredients may cause color, scent and/or taste variation.

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  • QUESTIONS

    Questions? Call 866.642.2858
    Uriel, East Troy, WI 53120
    www.urielpharmacy.com

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  • INGREDIENTS AND APPEARANCE
    ARNICA SCORODITE 
    arnica scorodite liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:48951-1155
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COLLOIDAL SILICON DIOXIDE (COLLOIDAL SILICON DIOXIDE) COLLOIDAL SILICON DIOXIDE 6 [hp_X]  in 1 mL
    ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 6 [hp_X]  in 1 mL
    OSTREA EDULIS SHELL (OSTREA EDULIS SHELL) OSTREA EDULIS SHELL 6 [hp_X]  in 1 mL
    LEVISTICUM OFFICINALE ROOT (LEVISTICUM OFFICINALE ROOT) LEVISTICUM OFFICINALE ROOT 6 [hp_X]  in 1 mL
    SODIUM CARBONATE (CARBONATE ION) SODIUM CARBONATE 6 [hp_X]  in 1 mL
    ORCHIS MASCULA TUBER (ORCHIS MASCULA TUBER) ORCHIS MASCULA TUBER 6 [hp_X]  in 1 mL
    FLUORAPATITE (FLUORAPATITE) FLUORAPATITE 7 [hp_X]  in 1 mL
    FERROUS ARSENATE (FERROUS ARSENATE) FERROUS ARSENATE 7 [hp_X]  in 1 mL
    BOS TAURUS CEREBELLUM (BOS TAURUS CEREBELLUM) BOS TAURUS CEREBELLUM 8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48951-1155-1 10 in 1 BOX
    1 1 mL in 1 AMPULE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    Name Address ID/FEI Business Operations
    Uriel Pharmacy Inc. 043471163 manufacture(48951-1155)
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