Arnica Betula B by Uriel Pharmacy Inc. ARNICA BETULA B liquid

Arnica Betula B by

Drug Labeling and Warnings

Arnica Betula B by is a Homeopathic medication manufactured, distributed, or labeled by Uriel Pharmacy Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ARNICA BETULA B 
arnica betula b liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48951-1116
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) (BETULA PUBESCENS LEAF - UNII:84SOH0O3OO)	BETULA PUBESCENS LEAF	3 [hp_X]  in 1 mL
BETULA PUBESCENS BARK (UNII: 3R504894L9) (BETULA PUBESCENS BARK - UNII:3R504894L9)	BETULA PUBESCENS BARK	4 [hp_X]  in 1 mL
BOS TAURUS CEREBELLUM (UNII: Q09851U44F) (BOS TAURUS CEREBELLUM - UNII:Q09851U44F)	BOS TAURUS CEREBELLUM	17 [hp_X]  in 1 mL
BOS TAURUS BRAIN (UNII: A1YEE2DB8Z) (BOS TAURUS BRAIN - UNII:A1YEE2DB8Z)	BOS TAURUS BRAIN	17 [hp_X]  in 1 mL
BOS TAURUS PINEAL GLAND (UNII: Z7RM5NBH36) (BOS TAURUS PINEAL GLAND - UNII:Z7RM5NBH36)	BOS TAURUS PINEAL GLAND	17 [hp_X]  in 1 mL
SUS SCROFA EAR (UNII: 7DX2J287CV) (SUS SCROFA EAR - UNII:7DX2J287CV)	SUS SCROFA EAR	17 [hp_X]  in 1 mL
BOS TAURUS NERVE (UNII: 28G2U3MQJK) (BOS TAURUS NERVE - UNII:28G2U3MQJK)	BOS TAURUS NERVE	17 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X]  in 1 mL
BIFENTHRIN (UNII: 6B66JED0KN) (BIFENTHRIN - UNII:6B66JED0KN)	BIFENTHRIN	30 [hp_X]  in 1 mL
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P)	LEAD	30 [hp_X]  in 1 mL
HONEY (UNII: Y9H1V576FH) (HONEY - UNII:Y9H1V576FH)	HONEY	30 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48951-1116-1	10 in 1 BOX	09/01/2009
1		1 mL in 1 AMPULE; Type 0: Not a Combination Product

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(48951-1116)