BioTox T: Homeopathic Product Information

BIOTOX T- clostridium tetani and rhododendron tomentosum leafy twig liquid
The Wellness Center For Research and Education

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

ACTIVE INGREDIENTS:

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

INDICATIONS:

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

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.

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:

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.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Organic Ethanol

QUESTIONS:

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 50181-0058-1

Homeopathic

BioTox

T

1 fl oz (30 ml)

BioTox T
(click image for full-size original)
BIOTOX T
bacillus tetani, ledum palustre liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50181-0058
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOSTRIDIUM TETANI (CLOSTRIDIUM TETANI) CLOSTRIDIUM TETANI 30 [hp_C] in 1 mL
RHODODENDRON TOMENTOSUM LEAFY TWIG (LEDUM PALUSTRE TWIG) RHODODENDRON TOMENTOSUM LEAFY TWIG 30 [hp_C] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50181-0058-1 30 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 02/27/2018
Labeler — The Wellness Center For Research and Education (832363993)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (50181-0058), api manufacture (50181-0058), label (50181-0058), pack (50181-0058)

Revised: 06/2021 The Wellness Center For Research and Education

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