Systemic Detox (Berberis Vulgaris, Boldo, Chelidonium Majus, Lappa Major, Taraxacum Officinale, Trifolium Pratense, Hydrastis Canadensis, Condurango, Ginkgo Biloba, Tabebuia Impetiginosa, Con -

SYSTEMIC DETOX (BERBERIS VULGARIS, BOLDO, CHELIDONIUM MAJUS, LAPPA MAJOR, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, HYDRASTIS CANADENSIS, CONDURANGO, GINKGO BILOBA, TABEBUIA IMPETIGINOSA, CON
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NDC	43857-0435-1
Set ID	2cf7a85a-bc21-4aec-9901-d60b10086df3
Category	HUMAN OTC DRUG LABEL
Packager	BioActive Nutritional, Inc.
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENTS:

Berberis Vulgaris 3X, Boldo 3X, Chelidonium Majus 3X, Lappa Major 3X, Taraxacum Officinale 3X, Trifolium Pratense 3X, Hydrastis Canadensis 5X, Condurango 6X, Ginkgo Biloba 6X, Tabebuia Impetiginosa 6X, Conium Maculatum 12X, Hepar Sulphuris Calcareum 12X, Lycopodium Clavatum 12X, Sarsaparilla (Smilax Regelii) 12X, Aloe 30X, Echinacea (Angustifolia) 30X, Natrum Sulphuricum 30X, Nux Vomica 30X, Thuja Occidentalis 30X.
INDICATIONS:

For temporary relief of diarrhea (painless, clay colored); eczema with itching; hay fever, offensive discharge running from the nose, and dyspepsia with bitter taste.
WARNINGS:

If pregnant or breast-feeding, ask a health care 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 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:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
INDICATIONS:

For temporary relief of diarrhea (painless, clay colored); eczema with itching; hay fever, offensive discharge running from the nose, and dyspepsia with bitter taste.
INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol
QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com
PACKAGE LABEL DISPLAY:

BIOActive Nutritional

SYSTEMIC DETOX

HOMEOPATHIC

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

SYSTEMIC DETOX
berberis vulgaris, boldo, chelidonium majus, lappa major, taraxacum officinale, trifolium pratense, hydrastis canadensis, condurango, ginkgo biloba, tabebuia impetiginosa, conium maculatum, hepar sulphuris calcareum, lycopodium clavatum, sarsaparilla (smilax regelii), aloe, echinacea (angustifolia), natrum sulphuricum, nux vomica, thuja occidentalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0435
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	3 [hp_X] in 1 mL
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O)	PEUMUS BOLDUS LEAF	3 [hp_X] in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	3 [hp_X] in 1 mL
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3)	ARCTIUM LAPPA ROOT	3 [hp_X] in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	3 [hp_X] in 1 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828)	TRIFOLIUM PRATENSE FLOWER	3 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	5 [hp_X] in 1 mL
MARSDENIA CONDURANGO BARK (UNII: R23QIR6YBA) (MARSDENIA CONDURANGO BARK - UNII:R23QIR6YBA)	MARSDENIA CONDURANGO BARK	6 [hp_X] in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	6 [hp_X] in 1 mL
TABEBUIA IMPETIGINOSA BARK (UNII: 6GLA1946WX) (HANDROANTHUS IMPETIGINOSUS BARK - UNII:6GLA1946WX)	TABEBUIA IMPETIGINOSA BARK	6 [hp_X] in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	12 [hp_X] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X] in 1 mL
SMILAX REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SMILAX REGELII ROOT	12 [hp_X] in 1 mL
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	30 [hp_X] in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	30 [hp_X] in 1 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	30 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_X] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	30 [hp_X] 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:43857-0435-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	03/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/01/2017

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0435) , api manufacture(43857-0435) , label(43857-0435) , pack(43857-0435)

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Medic

SYSTEMIC DETOX (BERBERIS VULGARIS, BOLDO, CHELIDONIUM MAJUS, LAPPA MAJOR, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, HYDRASTIS CANADENSIS, CONDURANGO, GINKGO BILOBA, TABEBUIA IMPETIGINOSA, CON

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