Label: ARNICA BETULA A liquid

  • 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 November 14, 2023

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  • INDICATIONS & USAGE

    Directions: FOR ORAL USE.

  • DOSAGE & ADMINISTRATION

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

  • ACTIVE INGREDIENT

    Active Ingredients: Betula (Silver birch leaves) 3X,Betula (cort.) decoct. (Silver birch, bark dried) 4X,Cerebellum (Bovine cerebellum) 17X,Corpora quad. (Bovine Quadrigeminal plate) 17X,Hypophysis (Bovine pituitary gland) 17X,Iris - bovis (Bovine iris) 17X,Medulla oblong. (Bovine Myelencephalon) 17X,Nervus opticus (Bovine second cranial nerve) 17X,Retina et chor. (Bovine retina and choroid) 17X,Thalamus (Bovine thalamus) 17X,Arnica 30X,Chrysolith (Silicate of magnesium and iron) 30X,Formica (Red ant) 30X,Mel (Honey) 30X,Plumbum met.(Lead) 30X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Salt

  • PURPOSE

    Use: Temporary relief of headache.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use.

  • QUESTIONS

    Questions? Call 866.642.2858
    Uriel, East Troy, WI 53120
    shopuriel.com Lot:

  • PRINCIPAL DISPLAY PANEL

    Arnica Betula A Ampules

  • INGREDIENTS AND APPEARANCE
    ARNICA BETULA A 
    arnica betula a liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-1352
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETULA PENDULA LEAF (UNII: 5HW39H9KDH) (BETULA PENDULA LEAF - UNII:5HW39H9KDH) BETULA PENDULA LEAF3 [hp_X]  in 1 mL
    BOS TAURUS NERVE (UNII: 28G2U3MQJK) (BOS TAURUS NERVE - UNII:28G2U3MQJK) BOS TAURUS NERVE17 [hp_X]  in 1 mL
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER30 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 mL
    HONEY (UNII: Y9H1V576FH) (HONEY - UNII:Y9H1V576FH) HONEY30 [hp_X]  in 1 mL
    FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5) FORMICA RUFA30 [hp_X]  in 1 mL
    LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD30 [hp_X]  in 1 mL
    BOS TAURUS CEREBELLUM (UNII: Q09851U44F) (BOS TAURUS CEREBELLUM - UNII:Q09851U44F) BOS TAURUS CEREBELLUM17 [hp_X]  in 1 mL
    BOS TAURUS PITUITARY GLAND (UNII: 7JM57I419K) (BOS TAURUS PITUITARY GLAND - UNII:7JM57I419K) BOS TAURUS PITUITARY GLAND17 [hp_X]  in 1 mL
    C12-17 ALKANE (UNII: FW7807707B) (C12-17 ALKANE - UNII:FW7807707B) C12-17 ALKANE17 [hp_X]  in 1 mL
    BOS TAURUS EYE (UNII: VTW461N43P) (BOS TAURUS EYE - UNII:VTW461N43P) BOS TAURUS EYE17 [hp_X]  in 1 mL
    SUS SCROFA THALAMUS (UNII: 3D6Q7UV74J) (SUS SCROFA THALAMUS - UNII:3D6Q7UV74J) SUS SCROFA THALAMUS17 [hp_X]  in 1 mL
    BETULA PUBESCENS BARK (UNII: 3R504894L9) (BETULA PUBESCENS BARK - UNII:3R504894L9) BETULA PUBESCENS BARK4 [hp_X]  in 1 mL
    BOS TAURUS BRAIN (UNII: A1YEE2DB8Z) (BOS TAURUS BRAIN - UNII:A1YEE2DB8Z) BOS TAURUS BRAIN17 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-1352-110 in 1 BOX09/01/2009
    11 mL in 1 AMPULE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc.043471163manufacture(48951-1352)
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