Label: ARNICA BETULA B pellet
- NDC Code(s): 48951-1117-2
- Packager: Uriel Pharmacy Inc.
- 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 31, 2018
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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ACTIVE INGREDIENT
Active Ingredients: Betula (Silver birch leaves) 3X, Betula cort. (Silver birch, bark dried) 4X, Cerebellum (Bovine cerebellum) 17X, Corpora quad. (Bovine Quadrigeminal plate) 17X, Epiphysis (Bovine pineal body) 17X, Labyrinthus (Bovine inner ear) 17X, Medulla oblong. (Bovine Myelencephalon 17X, Nervus stat. (Bovine eighth cranial nerve) 17X, Arnica 30X, Onyx (Nat. Silicic acid with traces of iron oxide and carbon) 30X, Plumbum mellitum (Lead with honey) 30X
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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.
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INGREDIENTS AND APPEARANCE
ARNICA BETULA B
arnica betula b pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-1117 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] BETULA PUBESCENS BARK (UNII: 3R504894L9) (BETULA PUBESCENS BARK - UNII:3R504894L9) BETULA PUBESCENS BARK 4 [hp_X] BOS TAURUS CEREBELLUM (UNII: Q09851U44F) (BOS TAURUS CEREBELLUM - UNII:Q09851U44F) BOS TAURUS CEREBELLUM 17 [hp_X] BOS TAURUS BRAIN (UNII: A1YEE2DB8Z) (BOS TAURUS BRAIN - UNII:A1YEE2DB8Z) BOS TAURUS BRAIN 17 [hp_X] BOS TAURUS PINEAL GLAND (UNII: Z7RM5NBH36) (BOS TAURUS PINEAL GLAND - UNII:Z7RM5NBH36) BOS TAURUS PINEAL GLAND 17 [hp_X] SUS SCROFA EAR (UNII: 7DX2J287CV) (SUS SCROFA EAR - UNII:7DX2J287CV) SUS SCROFA EAR 17 [hp_X] BOS TAURUS NERVE (UNII: 28G2U3MQJK) (BOS TAURUS NERVE - UNII:28G2U3MQJK) BOS TAURUS NERVE 17 [hp_X] ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 30 [hp_X] BIFENTHRIN (UNII: 6B66JED0KN) (BIFENTHRIN - UNII:6B66JED0KN) BIFENTHRIN 30 [hp_X] LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD 30 [hp_X] HONEY (UNII: Y9H1V576FH) (HONEY - UNII:Y9H1V576FH) HONEY 30 [hp_X] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-1117-2 1350 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/01/2009 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(48951-1117)