Label: ARNICA BETULA A pellet

  • 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 May 23, 2018

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

  • INDICATIONS & USAGE

    Directions: FOR ORAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredients: Betula (Silver birch leaves) 3X, Betula (Silver birch bark) 4X, Cerebellum (Bovine cerebellum) 17X, Corpora quadrig. (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 wood ant) 30X, Plumbum mellitum (Lead with honey) 30X

  • INACTIVE INGREDIENT

    Inactive Ingredient: Organic sucrose

  • 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. Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. 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. Do not use if safety seal is broken or missing.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    ArnicaBetulaAPellets

  • INGREDIENTS AND APPEARANCE
    ARNICA BETULA A 
    arnica betula a pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-1115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) (BETULA PUBESCENS LEAF - UNII:84SOH0O3OO) BETULA PUBESCENS LEAF3 [hp_X]
    BETULA PUBESCENS BARK (UNII: 3R504894L9) (BETULA PUBESCENS BARK - UNII:3R504894L9) BETULA PUBESCENS BARK4 [hp_X]
    BOS TAURUS CEREBELLUM (UNII: Q09851U44F) (BOS TAURUS CEREBELLUM - UNII:Q09851U44F) BOS TAURUS CEREBELLUM17 [hp_X]
    BOS TAURUS BRAIN (UNII: A1YEE2DB8Z) (BOS TAURUS BRAIN - UNII:A1YEE2DB8Z) BOS TAURUS BRAIN17 [hp_X]
    BOS TAURUS PITUITARY GLAND (UNII: 7JM57I419K) (BOS TAURUS PITUITARY GLAND - UNII:7JM57I419K) BOS TAURUS PITUITARY GLAND17 [hp_X]
    BOS TAURUS EYE (UNII: VTW461N43P) (BOS TAURUS EYE - UNII:VTW461N43P) BOS TAURUS EYE17 [hp_X]
    BOS TAURUS NERVE (UNII: 28G2U3MQJK) (BOS TAURUS NERVE - UNII:28G2U3MQJK) BOS TAURUS NERVE17 [hp_X]
    SUS SCROFA THALAMUS (UNII: 3D6Q7UV74J) (SUS SCROFA THALAMUS - UNII:3D6Q7UV74J) SUS SCROFA THALAMUS17 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]
    LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-1115-21350 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/01/2009
    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(48951-1115)