MedPath
FDA Approval

BioTox Hep

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
The Wellness Center for Research and Education, Inc.
DUNS: 832363993
Effective Date
May 28, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Horseradish(3 [hp_X] in 1 mL)
chelidonium majus whole(3 [hp_X] in 1 mL)
Arsenic trioxide(6 [hp_X] in 1 mL)
sus scrofa spleen(8 [hp_X] in 1 mL)
sus scrofa thymus(8 [hp_X] in 1 mL)
Hepatitis C virus inhibitors(Progenics)(17 [hp_X] in 1 mL)
hepatitis B virus vaccine(32 [hp_X] in 1 mL)
hepatitis A virus vaccine(17 [hp_X] in 1 mL)
Beef liver(8 [hp_X] in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Apotheca Company

844330915

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Apotheca Company

The Wellness Center for Research and Education, Inc.

Apotheca Company

844330915

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

BioTox Hep

Product Details

NDC Product Code
50181-0055
Route of Administration
ORAL
Effective Date
May 28, 2025
HorseradishActive
Code: 8DS6G120HJClass: ACTIBQuantity: 3 [hp_X] in 1 mL
chelidonium majus wholeActive
Code: 7E889U5RNNClass: ACTIBQuantity: 3 [hp_X] in 1 mL
Arsenic trioxideActive
Code: S7V92P67HOClass: ACTIBQuantity: 6 [hp_X] in 1 mL
sus scrofa spleenActive
Code: 92AMN5J79YClass: ACTIBQuantity: 8 [hp_X] in 1 mL
sus scrofa thymusActive
Code: 7B69B0BD62Class: ACTIBQuantity: 8 [hp_X] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
Hepatitis C virus inhibitors(Progenics)Active
Code: QI56415283Class: ACTIBQuantity: 17 [hp_X] in 1 mL
hepatitis B virus vaccineActive
Code: 77H9EM77P7Class: ACTIBQuantity: 32 [hp_X] in 1 mL
hepatitis A virus vaccineActive
Code: G54MT8V18GClass: ACTIBQuantity: 17 [hp_X] in 1 mL
Beef liverActive
Code: 6EC706HI7FClass: ACTIBQuantity: 8 [hp_X] in 1 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL DISPLAY:

Dr. Theresa Dale's

NDC 50181-0055-1

Homeopathic

BioTox

Hep

1 fl oz (30 ml)

BioTox Hep

BioTox Hep

INDICATIONS & USAGE SECTION

INDICATIONS:

Fatigue, fever, cough, flu-like symptoms, virus, pain, swelling, and stiffness of limbs.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS:

5 drops 2 or 3 times per day, on an empty stomach, 5 days per week or until symptoms abate. Consult a physician for use in children under 12 years of age.

WARNINGS SECTION

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.

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

Cochlearia Armoracia 3X, Chelidonium Majus 3X, 6X, 8X, Arsenicum Album 6X, 8X, 12X, 30C, Hepar Suis 8X, 12X 30C, Spleen (Suis) 8X, 30C, Thymus (Suis) 8X, 1LM, Hepatitis C Nosode 17X, 30C, 60C, 1M, Hepatitis A Nosode 17X, 30C, 3LM, Hepatitis B Nosode 32X, 30C, 3LM.

OTC - PURPOSE SECTION

INDICATIONS:

Fatigue, fever, cough, flu-like symptoms, virus, pain, swelling, and stiffness of limbs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - QUESTIONS SECTION

QUESTIONS:

MFD FOR:

The Wellness Center for

Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard CA 93035

1-866-962-6484

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy