BIOTOX GUT- cochlearia armoracia, phytolacca decandra, chelidonium majus, intestinal mucosa, spleen, hepar bovine, thymus, salmonella enteritidis, helicobacter pylori, nux vomica, salmonella paratyphi, botulinum 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:

Cochlearia Armoracia 3X, Phytolacca Decandra 3X, 6X, Chelidonium Majus 3X, 6X, 8X, Intestinal Mucosa (Bovine) 8X, Spleen (Suis) 8X, Hepar Bovine 8X, 30C, Thymus (Suis) 8X, 1LM, Salmonella Enteritidis 12X, 15X 30X, 30C, 60C, Helicobacter Pylori 15X, 30X, 30C, 60C, Nux Vomica 3C, Salmonella Paratyphi 15C, 30C, 60C, Botulinum 30C.

INDICATIONS:

Skin rash, headache, mental and physical fatigue, fever, cough, vomiting, flu-like symptoms, heart palpitations, virus, pain, belching, diarrhea, food poisoning, stiffness of limbs.

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 2 or 3 times per day, on an empty stomach, 5 days per week or until symptoms abate. Consult a physician for use in children under 12 years of age.

INDICATIONS:

Skin rash, headache, mental and physical fatigue, fever, cough, vomiting, flu-like symptoms, heart palpitations, virus, pain, belching, diarrhea, food poisoning, stiffness of limbs.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

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: 50181-0035-1

Homeopathic

BioTox Gut

1 FL OZ (30 ml)

BioTox Gut

BIOTOX GUT
cochlearia armoracia, phytolacca decandra, chelidonium majus, intestinal mucosa, spleen, hepar bovine, thymus, salmonella enteritidis, helicobacter pylori, nux vomica, salmonella paratyphi, botulinum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50181-0035
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ)	HORSERADISH	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [hp_X] in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	3 [hp_X] in 1 mL
BOS TAURUS INTESTINAL MUCOSA (UNII: 0989HO597G) (BOS TAURUS INTESTINAL MUCOSA - UNII:0989HO597G)	BOS TAURUS INTESTINAL MUCOSA	8 [hp_X] in 1 mL
SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y)	SUS SCROFA SPLEEN	8 [hp_X] in 1 mL
BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022)	BEEF LIVER	8 [hp_X] in 1 mL
SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62)	SUS SCROFA THYMUS	8 [hp_X] in 1 mL
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS (UNII: Y3V16D4PV4) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS - UNII:Y3V16D4PV4)	SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS	12 [hp_X] in 1 mL
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z)	HELICOBACTER PYLORI	15 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	3 [hp_C] in 1 mL
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI (UNII: 760T5R8B3O) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI - UNII:760T5R8B3O)	SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI	15 [hp_C] in 1 mL
BOTULINUM TOXIN TYPE A (UNII: E211KPY694) (ABOBOTULINUMTOXINA - UNII:E211KPY694)	BOTULINUM TOXIN TYPE A	30 [hp_C] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50181-0035-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/03/2014

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

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(50181-0035) , api manufacture(50181-0035) , label(50181-0035) , pack(50181-0035)