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

SILICEA COMPLEX by

Drug Labeling and Warnings

SILICEA COMPLEX by is a Homeopathic medication manufactured, distributed, or labeled by BioActive Nutritional, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INDICATIONS & USAGE

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0536-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/07/2019

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

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

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