SILICEA COMPLEX II- echinacea (angustifolia), trifolium pratense, phytolacca decandra, calcarea iodata, kali chloricum, nitricum acidum, phosphoricum acidum, sulphur iodatum, silicone (dimethicone). 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:

Echinacea (Angustifolia) 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Calcarea Iodata 12X, Kali Chloricum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Sulphur Iodatum 12X, Silicone (Dimethicone)12X, 30X, 200X.

INDICATIONS:

For temporary relief of symptoms related to headaches, cold hands and feet, and spasms.

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 a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical attention 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.

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 Homeopathic

SILICEA COMPLEX II

HOMEOPATHIC

1 FL OZ (30 ml)

SILICEA COMPLEX II

SILICEA COMPLEX II
echinacea (angustifolia), trifolium pratense, phytolacca decandra, calcarea iodata, kali chloricum, nitricum acidum, phosphoricum acidum, sulphur iodatum, silicone (dimethicone). liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0536
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	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
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	4 [hp_X] in 1 mL
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM IODIDE	12 [hp_X] in 1 mL
POTASSIUM CHLORATE (UNII: H35KS68EE7) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORATE	12 [hp_X] in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	12 [hp_X] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	12 [hp_X] in 1 mL
SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0)	SULFUR IODIDE	12 [hp_X] in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12 [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:43857-0536-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/07/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/07/2019

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0536) , api manufacture(43857-0536) , label(43857-0536) , pack(43857-0536)