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NDC 50181-0082-01 BioTox Dental Foci Repair 4; 3; 6; 6; 6; 3; 4; 3; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Details

BioTox Dental Foci Repair 4; 3; 6; 6; 6; 3; 4; 3; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL

BioTox Dental Foci Repair is a ORAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by The Wellness Center For Research and Education. The primary component is ACONITUM NAPELLUS WHOLE; ARNICA MONTANA WHOLE; ATROPA BELLADONNA; CALCIUM SULFIDE; HEKLA LAVA; HYPERICUM PERFORATUM WHOLE; MERCURIUS SOLUBILIS; PLANTAGO MAJOR WHOLE; SILICON DIOXIDE; SILVER NITRATE.

Product Information

NDC	50181-0082
Product ID	50181-0082_8aefd943-b50a-42ee-9158-71a2bad715bf
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BioTox Dental Foci Repair
Proprietary Name Suffix	n/a
Non-Proprietary Name	Arnica Montana, Hypericum Perforatum, Plantago Major, Aconitum Napellus, Mercurius Solubilis, Hekla Lava, Argentum Nitricum, Belladonna, Hepar Sulphuris Calcareum, Silicea
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	ORAL
Active Ingredient Strength	4; 3; 6; 6; 6; 3; 4; 3; 6; 6
Active Ingredient Units	[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Substance Name	ACONITUM NAPELLUS WHOLE; ARNICA MONTANA WHOLE; ATROPA BELLADONNA; CALCIUM SULFIDE; HEKLA LAVA; HYPERICUM PERFORATUM WHOLE; MERCURIUS SOLUBILIS; PLANTAGO MAJOR WHOLE; SILICON DIOXIDE; SILVER NITRATE
Labeler Name	The Wellness Center For Research and Education
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50181-0082-01 (50181008201)

Pricing Information	N/A
NDC Package Code	50181-0082-1
Billing NDC	50181008201
Package	30 mL in 1 BOTTLE, SPRAY (50181-0082-1)
Marketing Start Date	2022-02-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 767f8dd2-759f-4662-9b5c-b8832309363d Details

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:

For Temporary relief from right-sided tooth discomfort, dental abscess, tooth decay, loose teeth, nerve pain and general oral discomfort, Supports the body's natural slowing of excess bleeding. Promotes healthy gums.

WARNINGS:

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Spray orally, 2 to 4 sprays twice daily on affected teeth or gums, at least 30 minutes before or after eating. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INACTIVE INGREDIENTS:

Demineralized Water, 25% Organic Ethanol.

QUESTONS:

MFD FOR: The Wellness Center for

Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

PACKAGE LABEL DISPLAY:

Dr. Theresa Dale's

NDC 50181-0082-1

Homeopathic

BioTox

Dental Foci

Repair

1 fl oz (30 ml)

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 spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50181-0082
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50181-0082-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/14/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/14/2022

Labeler - The Wellness Center For Research and Education (832363993)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(50181-0082, 50181-0082) , api manufacture(50181-0082) , label(50181-0082)

Revised: 2/2022

Document Id: 8aefd943-b50a-42ee-9158-71a2bad715bf

Set id: 767f8dd2-759f-4662-9b5c-b8832309363d

Version: 1

Effective Time: 20220214

Search by Drug Name or NDC

NDC 50181-0082-01 BioTox Dental Foci Repair 4; 3; 6; 6; 6; 3; 4; 3; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Details

BioTox Dental Foci Repair 4; 3; 6; 6; 6; 3; 4; 3; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL

Product Information

Package

Package Images

NDC 50181-0082-01 (50181008201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 767f8dd2-759f-4662-9b5c-b8832309363d Details

ACTIVE INGREDIENTS:

INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

INDICATIONS:

INACTIVE INGREDIENTS:

QUESTONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

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