BIOTOX T- bacillus tetani, ledum palustre 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.

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Drug Facts:

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

BIOTOX T 
bacillus tetani, ledum palustre liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0058
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOSTRIDIUM TETANI (UNII: 751E8J54VM) (CLOSTRIDIUM TETANI - UNII:751E8J54VM) CLOSTRIDIUM TETANI30 [hp_C]  in 1 mL
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG30 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50181-0058-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/27/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/27/2018
Labeler - The Wellness Center For Research and Education (832363993)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(50181-0058) , api manufacture(50181-0058) , label(50181-0058) , pack(50181-0058)

Revised: 6/2021
Document Id: 7e4e9b10-0acf-4c34-9a1a-6c41230e6208
Set id: 7c6ed561-340d-4053-bec0-8be0906bbcd8
Version: 2
Effective Time: 20210616
 
The Wellness Center For Research and Education