FDA.reportPublic FDA data

BioTox T

Manufacturer
The Wellness Center For Research and Education | Apotheca Company
Effective date
2025-05-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:33:53

Label at a glance#

ProductBioTox T
Active ingredientCLOSTRIDIUM TETANI, RHODODENDRON TOMENTOSUM LEAFY TWIG
Label structure9 sections

Dosage and administration

5 drops orally 2 or 3 times per day, 5 days per week until symptoms improve, then 3 drops 3 times daily for 3 days per week until symptoms abate. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Bacillus Tetani 30C, 2LM, Ledum Palustre 30C, 2LM.

INDICATIONS:

OTC - PURPOSE SECTION

For symptoms of stiffness, muscle spasms, difficulty swallowing, irritability, excess sweating, anxiety.

WARNINGS:

WARNINGS SECTION

If you are pregnant or breastfeeding, 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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

5 drops orally 2 or 3 times per day, 5 days per week until symptoms improve, then 3 drops 3 times daily for 3 days per week until symptoms abate. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For symptoms of stiffness, muscle spasms, difficulty swallowing, irritability, excess sweating, anxiety.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Organic Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

MFD FOR:

The Wellness Center for Research

and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035 

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Theresa Dale's

NDC 50181-0058-1

Homeopathic

BioTox

T

1 fl oz (30 ml)

BioTox TBioTox T

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50181-0058-12025-05-30C16284748780-1f386c64a-1d0d-0266-e053-dadaa90a7c1aDrug Facts:
50181-0058-12023-01-30C16284748780-1f386c64a-1d0d-0266-e053-dadaa90a7c1aDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50181-0058-1BioTox T30 mL in 1 BOTTLE, DROPPERLIQUID303

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50181-005850181-0058-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOSTRIDIUM TETANI751E8J54VMACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d1972def-8641-45ee-b714-2c6d815ee89f7c6ed561-340d-4053-bec0-8be0906bbcd82025-05-30WarningsExact identifier
spl id: d1972def-8641-45ee-b714-2c6d815ee89f
spl set id: 7c6ed561-340d-4053-bec0-8be0906bbcd8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.