BIOTOX BAC 3- mycoplasma pneumoniae, proteus (vulgaris), candida albicans, colibacillinum cum natrum muriaticum, mycobacterium paratuberculosis, pasteurellosis (pasteurella multocida), pneumococcinum, thuja occidentalis, mycobacterium avium paratuberculosis, phytolacca decandra, legionella pneumophila, shigella sonnei 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:

Mycoplasma Pneumoniae 9X, 30X, 60X, Proteus (Vulgaris) 12X, 30X, 60X, Candida Albicans 15X, 30X, 60X, Colibacillinum Cum Natrum Muriaticum 15X, 30X, 60X, Mycobacterium Paratuberculosis 15X, 30X, 60X, Pasteurellosis (Pasteurella Multocida) 15X, 30X, 60X, Pneumococcinum 15X, 30X, 60X, Thuja Occidentalis 15X, 30X, 60X, Mycobacterium Avium Paratuberculosis 28X, 30X, 60X, Phytolacca Decandra 6C, 12C, 30C, 60C, Legionella Pneumophila 15C, 30C, 60C, Shigella Sonnei 15C, 30C, 60C.

INDICATIONS:

For temporary relief of fever and chills. Promotes a productive wet cough and the coughing up of phlegm. expectorant. Helps relieve the presence of mucus in the stool 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 temporary relief of fever and chills. Promotes a productive wet cough and the coughing up of phlegm. expectorant. Helps relieve the presence of mucus in the stool 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 50181-0078-1

Homeopathic

BioTox Bac 3

1 fl oz (30 ml)

BioTox Bac 3

BIOTOX BAC 3
mycoplasma pneumoniae, proteus (vulgaris), candida albicans, colibacillinum cum natrum muriaticum, mycobacterium paratuberculosis, pasteurellosis (pasteurella multocida), pneumococcinum, thuja occidentalis, mycobacterium avium paratuberculosis, phytolacca decandra, legionella pneumophila, shigella sonnei liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50181-0078
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MYCOPLASMA PNEUMONIAE (UNII: JQE470FAD0) (MYCOPLASMA PNEUMONIAE - UNII:JQE470FAD0)	MYCOPLASMA PNEUMONIAE	9 [hp_X] in 1 mL
PROTEUS INCONSTANS (UNII: UTX536WN6N) (PROTEUS INCONSTANS - UNII:UTX536WN6N)	PROTEUS INCONSTANS	12 [hp_X] in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	15 [hp_X] in 1 mL
ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10)	ESCHERICHIA COLI	15 [hp_X] in 1 mL
MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS (UNII: XH0F4IP2RX) (MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS - UNII:XH0F4IP2RX)	MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS	15 [hp_X] in 1 mL
PASTEURELLA MULTOCIDA (UNII: IX56B2GQX6) (PASTEURELLA MULTOCIDA - UNII:IX56B2GQX6)	PASTEURELLA MULTOCIDA	15 [hp_X] in 1 mL
STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2)	STREPTOCOCCUS PNEUMONIAE	15 [hp_X] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	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
LEGIONELLA PNEUMOPHILA (UNII: TJR6ZFY0F0) (LEGIONELLA PNEUMOPHILA - UNII:TJR6ZFY0F0)	LEGIONELLA PNEUMOPHILA	15 [hp_C] in 1 mL
SHIGELLA SONNEI (UNII: OO358E3009) (SHIGELLA SONNEI - UNII:OO358E3009)	SHIGELLA SONNEI	15 [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:50181-0078-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/08/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/08/2021

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(50181-0078) , api manufacture(50181-0078) , label(50181-0078) , pack(50181-0078)