Dosage and administration
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.
BioTox Dental Foci Repair
- Manufacturer
- The Wellness Center For Research and Education | Apotheca Company
- Effective date
- 2025-06-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:33:56
Label at a glance#
ProductBioTox Dental Foci Repair
Active ingredientARNICA MONTANA WHOLE, HYPERICUM PERFORATUM WHOLE, PLANTAGO MAJOR WHOLE, ACONITUM NAPELLUS WHOLE, MERCURIUS SOLUBILIS, HEKLA LAVA, SILVER NITRATE, ATROPA BELLADONNA, CALCIUM SULFIDE, SILICON DIOXIDE
Label structure9 sections
Label contents#
Full prescribing information#
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:
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.
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)
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6cca4355-1206-91f7-02de-17eef38a8622 | Product name | 1 | 20140508 |
| 751c581a-bf64-2fd7-b3ec-ca02c83e4a00 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50181-0082-1 | 2025-06-06 | C162847 | 48780-1 | 1030e365-5597-111a-e063-dadaa90a10e2 | DRUG FACTS: |
| 50181-0082-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5597-111a-e063-dadaa90a10e2 | DRUG FACTS: |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50181-0082-1 | BioTox Dental Foci Repair | 30 mL in 1 BOTTLE, SPRAY | SPRAY | 30 | 2 |
Products#
Every source-derived product name is available through these pages.
- BioTox Dental Foci Repair
- Arnica Montana, Hypericum Perforatum, Plantago Major, Aconitum Napellus, Mercurius Solubilis, Hekla Lava, Argentum Nitricum, Belladonna, Hepar Sulphuris Calcareum, Silicea
- ARNICA MONTANA WHOLE
- ARNICA MONTANA
- HYPERICUM PERFORATUM WHOLE
- HYPERICUM PERFORATUM
- PLANTAGO MAJOR WHOLE
- PLANTAGO MAJOR
- ACONITUM NAPELLUS WHOLE
- ACONITUM NAPELLUS
- MERCURIUS SOLUBILIS
- HEKLA LAVA
- SILVER NITRATE
- SILVER CATION
- ATROPA BELLADONNA
- CALCIUM SULFIDE
- SILICON DIOXIDE
- WATER
- ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50181-0082 | 50181-0082-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ARNICA MONTANA WHOLE | O80TY208ZW | ACTIB |
| HYPERICUM PERFORATUM WHOLE | XK4IUX8MNB | ACTIB |
| PLANTAGO MAJOR WHOLE | W2469WNO6U | ACTIB |
| ACONITUM NAPELLUS WHOLE | U0NQ8555JD | ACTIB |
| MERCURIUS SOLUBILIS | 324Y4038G2 | ACTIB |
| HEKLA LAVA | C21158IIRK | ACTIB |
| SILVER NITRATE | 95IT3W8JZE | ACTIB |
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| CALCIUM SULFIDE | 1MBW07J51Q | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BioTox Dental Foci Repair | ARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEA | The Wellness Center For Research and Education | 767f8dd2-759f-4662-9b5c-b8832309363d | 2025-06-06 | Warnings | 50181-0082-1 50181-0082 50181008201 ccb14ecf-89db-4afb-a89c-263c28afa851 767f8dd2-759f-4662-9b5c-b8832309363d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.