Label: BIOTOX DENTAL FOCI REPAIR- arnica montana, hypericum perforatum, plantago major, aconitum napellus, mercurius solubilis, hekla lava, argentum nitricum, belladonna, hepar sulphuris calcareum, silicea spray
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Contains inactivated NDC Code(s)
NDC Code(s): 50181-0082-1 - Packager: The Wellness Center For Research and Education
- Category: HUMAN OTC DRUG LABEL
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 February 14, 2022
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ACTIVE INGREDIENTS:
Arnica Montana 3C, 6C, 30C, 60C, 200C, Hypericum Perforatum 3C, 6C, 30C, 60C, 200C, Plantago Major 3C, 6C, 30C, 60C, 200C, Aconitum Napellus 4C, 6C, 30C, 60C,200C, Mercurius Solubilis 4C, 6C, 30C, 60C,200C, Hekla Lava 6C, 30C, Argentum Nitricum 6C, 30C, 60C, 200C, Belladonna 6C, 30C, 60C, 200C, Hepar Sulphuris Calcareum 6C, 30C, 60C, 200C, Silicea 6C, 30C, 60C, 200C.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
BIOTOX DENTAL FOCI REPAIR
arnica montana, hypericum perforatum, plantago major, aconitum napellus, mercurius solubilis, hekla lava, argentum nitricum, belladonna, hepar sulphuris calcareum, silicea sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50181-0082 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE 3 [hp_C] in 1 mL HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 3 [hp_C] in 1 mL PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR WHOLE 3 [hp_C] in 1 mL ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 4 [hp_C] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 4 [hp_C] in 1 mL HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA 6 [hp_C] in 1 mL SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 6 [hp_C] in 1 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 6 [hp_C] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_C] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 6 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50181-0082-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/14/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/14/2022 Labeler - The Wellness Center For Research and Education (832363993) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(50181-0082, 50181-0082) , api manufacture(50181-0082) , label(50181-0082)