Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 7c6ed561-340d-4053-bec0-8be0906bbcd8
Route
ORAL
Published
Effective Date 2021-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clostridium Tetani (30 [hp_C]) Ledum Palustre Twig
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-02-27 Until 2026-06-04

Description

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


Medication Information

Description

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

Warnings:

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.

Questions:

MFD FOR:

The Wellness Center for Research

and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035 

Directions:

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:

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

Active Ingredients:

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

Inactive Ingredients:

Demineralized Water, 25% Organic Ethanol

Package Label Display:

Dr. Theresa Dale's

NDC 50181-0058-1

Homeopathic

BioTox

T

1 fl oz (30 ml)

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.


Structured Label Content

Warnings: (WARNINGS:)

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.

Questions: (QUESTIONS:)

MFD FOR:

The Wellness Center for Research

and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035 

Directions: (DIRECTIONS:)

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:)

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

Active Ingredients: (ACTIVE INGREDIENTS:)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Organic Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

Dr. Theresa Dale's

NDC 50181-0058-1

Homeopathic

BioTox

T

1 fl oz (30 ml)

Keep Out of Reach of Children: (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.


Advanced Ingredient Data


Raw Label Data

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