DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

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

Berberis Vulgaris 3X, Boldo 3X, Hydrastis Canadensis 3X, Lappa Major 3X, Sanguinaria Canadensis 3X, Taraxacum Officinale 3X, Trifolium Pratense 3X, Condurango 6X, Ginko 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

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY

BioActive Homeopathic

SYSTEMIC DETOX

1 FL OZ (30 ml)

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0311
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	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
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS 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
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) (TABEBUIA IMPETIGINOSA 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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0311-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/22/2014	08/05/2019

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0311) , api manufacture(43857-0311) , label(43857-0311) , pack(43857-0311)

Revised: 8/2015

Document Id: 488c8b46-2c26-45b8-9414-ab75497d5e0f

Set id: 4ba4446a-a6c8-45a4-b776-b7efbf83534e

Version: 2

Effective Time: 20150806