BIOTOX HEP- cochlearia armoracia, chelidonium majus, arsenicum album, hepar suis, spleen (suis), thymus (suis), hepatitis c nosode, hepatitis a nosode, hepatitis b nosode 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, Chelidonium Majus 3X, 6X, 8X, Arsenicum Album 6X, 8X, 12X, 30C, Hepar Suis 8X, 12X 30C, Spleen (Suis) 8X, 30C, Thymus (Suis) 8X, 1LM, Hepatitis C Nosode 17X, 30C, 60C, 1M, Hepatitis A Nosode 17X, 30C, 3LM, Hepatitis B Nosode 32X, 30C, 3LM.

INDICATIONS:

Fatigue, fever, cough, flu-like symptoms, virus, pain, swelling, and 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:

Fatigue, fever, cough, flu-like symptoms, virus, pain, swelling, and 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 50181-0055-1

Homeopathic

BioTox

Hep

1 fl oz (30 ml)

BioTox Hep

BIOTOX HEP 
cochlearia armoracia, chelidonium majus, arsenicum album, hepar suis, spleen (suis), thymus (suis), hepatitis c nosode, hepatitis a nosode, hepatitis b nosode liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0055
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH3 [hp_X]  in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [hp_X]  in 1 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER8 [hp_X]  in 1 mL
SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y) SUS SCROFA SPLEEN8 [hp_X]  in 1 mL
SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62) SUS SCROFA THYMUS8 [hp_X]  in 1 mL
HEPATITIS C VIRUS (UNII: QI56415283) (HEPATITIS C VIRUS - UNII:QI56415283) HEPATITIS C VIRUS17 [hp_X]  in 1 mL
HEPATITIS A VIRUS (UNII: G54MT8V18G) (HEPATITIS A VIRUS - UNII:G54MT8V18G) HEPATITIS A VIRUS17 [hp_X]  in 1 mL
HEPATITIS B VIRUS (UNII: 77H9EM77P7) (HEPATITIS B VIRUS - UNII:77H9EM77P7) HEPATITIS B VIRUS32 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50181-0055-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/15/2015
Labeler - The Wellness Center for Research and Education, Inc. (832363993)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(50181-0055) , api manufacture(50181-0055) , label(50181-0055) , pack(50181-0055)

Revised: 10/2015
Document Id: e4b23bfb-9493-4abc-b02a-f63ec38edadb
Set id: 9da1043b-ceea-4613-a2f9-56f7d23455bb
Version: 1
Effective Time: 20151015
 
The Wellness Center for Research and Education, Inc.