SILICEA COMPLEX II- echinacea (angustifolia), phytolacca decandra, trifolium pratense, 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,  PHYTOLACCA DECANDRA 3X,  TRIFOLIUM PRATENSE 3X,  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:

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

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

SILICEA COMPLEX II

1 FL OZ (30 ml)

SILICEA COMPLEX II

SILICEA COMPLEX II

SILICEA COMPLEX  II
echinacea (angustifolia), phytolacca decandra, trifolium pratense, calcarea iodata, kali chloricum, nitricum acidum, phosphoricum acidum, sulphur iodatum, silicone (dimethicone) liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0339
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER3 [hp_X]  in 1 mL
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE12 [hp_X]  in 1 mL
POTASSIUM CHLORATE (UNII: H35KS68EE7) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORATE12 [hp_X]  in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID12 [hp_X]  in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0) SULFUR IODIDE12 [hp_X]  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0339-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/15/201411/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/15/201411/12/2023
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0339) , api manufacture(43857-0339) , label(43857-0339) , pack(43857-0339)

Revised: 8/2023
Document Id: cb7dc7a3-a6c2-4d2d-b2c1-912383e80962
Set id: 59f8d5aa-60e0-4118-90db-35a27c4a8a57
Version: 2
Effective Time: 20230828
 
BioActive Nutritional, Inc.