BIOTOX BAC 2- bacillus tetani, chlamydia trachomatis, streptococcus viridans, meningococcus nosode, phytolacca decandra, pneumococcinum, clostridium perfringens, dysentery bacillus, enterococcus faecalis, listeria monocytogenes, streptococcus agalactiae, streptococcus dysgalactiae, streptococcus mutans, streptococcus bovis, streptococcus uberis liquid 
The Wellness Center for Research and Education, Inc.

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 15X, 30X, 60X, Chlamydia Trachomatis 15X 30X, 60X, Streptococcus Viridans 15X, 30X, 60, Meningococcus Nosode 27X, 30X, 60X, Phytolacca Decandra 6C, 12C, 30C, 60C, Pneumococcinum 12C, 30C, 60C, Clostridium Perfringens 15C, 30C, 60C, Dysentery Bacillus 15C, 30C, 60C, Enterococcus Faecalis 15C, 30C, 60C, Listeria Monocytogenes 15C, 30C, 60C, Streptococcus Agalactiae 15C, 30C, 60C, Streptococcus Dysgalactiae 15C, 30C, 60C, Streptococcus Mutans 15C, 30C, 60C, Streptococcus Bovis 32C, 60C, Streptococcus Uberis 32C, 60C.

INDICATIONS:

For the temporary relief of fever, sore throat, fatigue, pain and loose stools. 

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.

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 three times daily (under tongus), 5 days per week (between meals, food and beverage), unless otherwise directed by health provider.

Consult a physician for use in children under 12 years of age.

INDICATIONS:

For the temporary relief of fever, sore throat, fatigue, pain and loose stools.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Organic Ethanol

QUESTONS:

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 50181-0077-1

Homeopathic

BioTox Bac 2

1 fl oz (30 ml)

BioTox Bac 2

BIOTOX BAC  2
bacillus tetani, chlamydia trachomatis, streptococcus viridans, meningococcus nosode, phytolacca decandra, pneumococcinum, clostridium perfringens, dysentery bacillus, enterococcus faecalis, listeria monocytogenes, streptococcus agalactiae, streptococcus dysgalactiae, streptococcus mutans, streptococcus bovis, streptococcus uberis liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0077
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOSTRIDIUM TETANI (UNII: 751E8J54VM) (CLOSTRIDIUM TETANI - UNII:751E8J54VM) CLOSTRIDIUM TETANI15 [hp_X]  in 1 mL
CHLAMYDIA TRACHOMATIS (UNII: T6NI39QU44) (CHLAMYDIA TRACHOMATIS - UNII:T6NI39QU44) CHLAMYDIA TRACHOMATIS15 [hp_X]  in 1 mL
STREPTOCOCCUS VIRIDANS GROUP (UNII: NNV2379HKR) (STREPTOCOCCUS VIRIDANS GROUP - UNII:NNV2379HKR) STREPTOCOCCUS VIRIDANS GROUP15 [hp_X]  in 1 mL
NEISSERIA MENINGITIDIS (UNII: V3TP2MD7F3) (NEISSERIA MENINGITIDIS - UNII:V3TP2MD7F3) NEISSERIA MENINGITIDIS27 [hp_X]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT6 [hp_C]  in 1 mL
STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2) STREPTOCOCCUS PNEUMONIAE12 [hp_C]  in 1 mL
CLOSTRIDIUM PERFRINGENS (UNII: OVP6XX033E) (CLOSTRIDIUM PERFRINGENS - UNII:OVP6XX033E) CLOSTRIDIUM PERFRINGENS15 [hp_C]  in 1 mL
SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J) (SHIGELLA DYSENTERIAE - UNII:1EP6R5562J) SHIGELLA DYSENTERIAE15 [hp_C]  in 1 mL
ENTEROCOCCUS FAECALIS (UNII: 15E04LZ9CT) (ENTEROCOCCUS FAECALIS - UNII:15E04LZ9CT) ENTEROCOCCUS FAECALIS15 [hp_C]  in 1 mL
LISTERIA MONOCYTOGENES (UNII: 3O44K14A86) (LISTERIA MONOCYTOGENES - UNII:3O44K14A86) LISTERIA MONOCYTOGENES15 [hp_C]  in 1 mL
STREPTOCOCCUS AGALACTIAE (UNII: 2B3763S671) (STREPTOCOCCUS AGALACTIAE - UNII:2B3763S671) STREPTOCOCCUS AGALACTIAE15 [hp_C]  in 1 mL
STREPTOCOCCUS DYSGALACTIAE (UNII: LN0SH02Y5M) (STREPTOCOCCUS DYSGALACTIAE - UNII:LN0SH02Y5M) STREPTOCOCCUS DYSGALACTIAE15 [hp_C]  in 1 mL
STREPTOCOCCUS MUTANS (UNII: 5C7J33MJJ1) (STREPTOCOCCUS MUTANS - UNII:5C7J33MJJ1) STREPTOCOCCUS MUTANS15 [hp_C]  in 1 mL
STREPTOCOCCUS EQUINUS (UNII: R2P4NKP3ZK) (STREPTOCOCCUS EQUINUS - UNII:R2P4NKP3ZK) STREPTOCOCCUS EQUINUS32 [hp_C]  in 1 mL
STREPTOCOCCUS UBERIS (UNII: O84V4ZK4BX) (STREPTOCOCCUS UBERIS - UNII:O84V4ZK4BX) STREPTOCOCCUS UBERIS32 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50181-0077-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/04/2021
Labeler - The Wellness Center for Research and Education, Inc. (832363993)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(50181-0077) , api manufacture(50181-0077) , label(50181-0077) , pack(50181-0077)

Revised: 10/2021
Document Id: 7d1a0ddf-f967-4981-a333-6bab93adbb4d
Set id: 1554cd2d-e064-46f1-a635-2c80191a7b9e
Version: 1
Effective Time: 20211004
 
The Wellness Center for Research and Education, Inc.