Label: ARNICA BETULA B 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 April 16, 2018

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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 e fol. (Silver birch leaves) 3X, Betula (cort.) dec. (Silver birch, bark dried) 4X, Cerebellum (Bovine cerebellum) 17X, Corpora quadrigemina (Bovine Quadrigeminal plate) 17X, Epiphysis (Bovine pineal body) 17X, Labyrinthus (Bovine inner ear) 17X, Medulla oblong. (ventr. quart.) (Bovine Myelencephalon ) 17X, Nervus statoacusticus (Bovine eighth cranial nerve) 17X, Arnica e pl. tota (Arnica) 30X, Onyx (Nat. Silicic acid with traces of iron oxide and carbon) 30X, Plumbum mellitum (Lead with honey) 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 Made by Uriel, East Troy, WI 53120 www.urielpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    ArnicaBetulaBAmpule

  • INGREDIENTS AND APPEARANCE
    ARNICA BETULA B 
    arnica betula b liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-1116
    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]  in 1 mL
    BETULA PUBESCENS BARK (UNII: 3R504894L9) (BETULA PUBESCENS BARK - UNII:3R504894L9) BETULA PUBESCENS BARK4 [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 BRAIN (UNII: A1YEE2DB8Z) (BOS TAURUS BRAIN - UNII:A1YEE2DB8Z) BOS TAURUS BRAIN17 [hp_X]  in 1 mL
    BOS TAURUS PINEAL GLAND (UNII: Z7RM5NBH36) (BOS TAURUS PINEAL GLAND - UNII:Z7RM5NBH36) BOS TAURUS PINEAL GLAND17 [hp_X]  in 1 mL
    SUS SCROFA EAR (UNII: 7DX2J287CV) (SUS SCROFA EAR - UNII:7DX2J287CV) SUS SCROFA EAR17 [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 (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 mL
    BIFENTHRIN (UNII: 6B66JED0KN) (BIFENTHRIN - UNII:6B66JED0KN) BIFENTHRIN30 [hp_X]  in 1 mL
    LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD30 [hp_X]  in 1 mL
    HONEY (UNII: Y9H1V576FH) (HONEY - UNII:Y9H1V576FH) HONEY30 [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:48951-1116-110 in 1 BOX09/01/2009
    11 mL in 1 AMPULE; Type 0: Not a Combination Product
    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(48951-1116)
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