BIOTOX BAC 2- streptococcus viridans, chlamydia trachomatis, bacillus tetani, meningococcus nosode, phytolacca decandra, streptococcus agalactiae, streptococcus pheumoniae, liquid

BIOTOX BAC by

Drug Labeling and Warnings

BIOTOX BAC by is a Homeopathic medication manufactured, distributed, or labeled by The Wellness Center for Research and Education, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Streptococcus viridans 8X, 12X, 30X, 60X, Chlamydia trachomatis 9X, 30X, 60X, Bacillus tetani 12X, 30X, 60X, Meningococcus nosode 15X, 30X, 60X, Phytolacca decandra 6C, 12C, 30C, 60C, Streptococcus agalactiae 6C, 12C, 30C, 60C, Streptococcus pheumoniae 6C, 12C, 30C, 60C, Enterococcus faecalis 9C, 30C, 60C, Streptococcus mutans 9C, 30C, 60C, Dysentery bacillus 12C, 30C, 60C, Listeria monocytogenes 12C, 30C, 60C, Streptococcus dysgalactiae 12C, 30C, 60C, Streptococcus uberis 12C, 30C, 60C, Clostridium pergringens 15C, 30C, 60C, Streptococcus bovis 30C, 60C.

INDICATIONS:

For temporary relief of inflammation, fever, coughing, aching, soreness, limb pain, pale skin, cold hands and feet, rash, sinus and/or throat mucus, glandular swelling, vaginal discharge, vaginal itching, burning when urinating.

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 tempoary relief of inflammation, fever, coughing, aching, soreness, limb pain, pale skin, cold hands and feet, rash, sinus and/or throat mucus, glandular swelling, vaginal discharge, vaginal itcdhing, burning when urinating.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTONS:

MFD FOR:

The Wellness Center for Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

1-866-962-6484

PACKAGE LABEL DISPLAY:

Dr. Theresa Dale's

NDC: 50181-0046-1

Homeopathic

BioTox Bac 2

1 fl oz (30 ml)

INGREDIENTS AND APPEARANCE

BIOTOX BAC  2
streptococcus viridans, chlamydia trachomatis, bacillus tetani, meningococcus nosode, phytolacca decandra, streptococcus agalactiae, streptococcus pheumoniae, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50181-0046
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STREPTOCOCCUS VIRIDANS GROUP (UNII: NNV2379HKR) (STREPTOCOCCUS VIRIDANS GROUP - UNII:NNV2379HKR)	STREPTOCOCCUS VIRIDANS GROUP	8 [hp_X]  in 1 mL
CHLAMYDIA TRACHOMATIS (UNII: T6NI39QU44) (CHLAMYDIA TRACHOMATIS - UNII:T6NI39QU44)	CHLAMYDIA TRACHOMATIS	9 [hp_X]  in 1 mL
CLOSTRIDIUM TETANI (UNII: 751E8J54VM) (CLOSTRIDIUM TETANI - UNII:751E8J54VM)	CLOSTRIDIUM TETANI	12 [hp_X]  in 1 mL
NEISSERIA MENINGITIDIS (UNII: V3TP2MD7F3) (NEISSERIA MENINGITIDIS - UNII:V3TP2MD7F3)	NEISSERIA MENINGITIDIS	15 [hp_X]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	6 [hp_C]  in 1 mL
STREPTOCOCCUS AGALACTIAE (UNII: 2B3763S671) (STREPTOCOCCUS AGALACTIAE - UNII:2B3763S671)	STREPTOCOCCUS AGALACTIAE	6 [hp_C]  in 1 mL
STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2)	STREPTOCOCCUS PNEUMONIAE	6 [hp_C]  in 1 mL
ENTEROCOCCUS FAECALIS (UNII: 15E04LZ9CT) (ENTEROCOCCUS FAECALIS - UNII:15E04LZ9CT)	ENTEROCOCCUS FAECALIS	9 [hp_C]  in 1 mL
STREPTOCOCCUS MUTANS (UNII: 5C7J33MJJ1) (STREPTOCOCCUS MUTANS - UNII:5C7J33MJJ1)	STREPTOCOCCUS MUTANS	9 [hp_C]  in 1 mL
SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J) (SHIGELLA DYSENTERIAE - UNII:1EP6R5562J)	SHIGELLA DYSENTERIAE	12 [hp_C]  in 1 mL
LISTERIA MONOCYTOGENES (UNII: 3O44K14A86) (LISTERIA MONOCYTOGENES - UNII:3O44K14A86)	LISTERIA MONOCYTOGENES	12 [hp_C]  in 1 mL
STREPTOCOCCUS DYSGALACTIAE (UNII: LN0SH02Y5M) (STREPTOCOCCUS DYSGALACTIAE - UNII:LN0SH02Y5M)	STREPTOCOCCUS DYSGALACTIAE	12 [hp_C]  in 1 mL
STREPTOCOCCUS UBERIS (UNII: O84V4ZK4BX) (STREPTOCOCCUS UBERIS - UNII:O84V4ZK4BX)	STREPTOCOCCUS UBERIS	12 [hp_C]  in 1 mL
CLOSTRIDIUM PERFRINGENS (UNII: OVP6XX033E) (CLOSTRIDIUM PERFRINGENS - UNII:OVP6XX033E)	CLOSTRIDIUM PERFRINGENS	15 [hp_C]  in 1 mL
STREPTOCOCCUS EQUINUS (UNII: R2P4NKP3ZK) (STREPTOCOCCUS EQUINUS - UNII:R2P4NKP3ZK)	STREPTOCOCCUS EQUINUS	30 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50181-0046-1	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/12/2014

Labeler - The Wellness Center for Research and Education, Inc. (832363993)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(50181-0046) , api manufacture(50181-0046) , label(50181-0046) , pack(50181-0046)