DRUG FACTS:

Drug Labeling and Warnings

Drug Details [pdf]

PROSTATONE HP- clematis erecta, conium maculatum, lycopodium clavatum, mercurius corrosivus, pulsatilla vulgaris, sabal serrulata, selenium metallicum, sepia, staphysagria, thuja occidentalis liquid 
BioActive Nutritional

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:

Clematis Erecta 30X, Conium Maculatum 30X, Lycopodium Clavatum 30X, Mercurius Corrosivus 30X, Pulsatilla 30X, Sabal Serrulata 30X, Selenium Metallicum 30X, Sepia 30X, Staphysagria 30X, Thuja Occidentalis 30X.

INDICATIONS:

For temporary relief of symptoms due to swelling and tenderness in the area of the prostate.

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 help or contact a Poison Control Center right away.

DIRECTIONS:

10 drops orally, 1-2 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of symptoms due to swelling and tenderness in the area of the prostate.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

BioActive Homeopathic

PROSTATONE-HP

1 FL OZ (30 ml)

PROSTATONE HP 
clematis erecta, conium maculatum, lycopodium clavatum, mercurius corrosivus, pulsatilla vulgaris, sabal serrulata, selenium metallicum, sepia, staphysagria, thuja occidentalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0224
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F)	CLEMATIS RECTA FLOWERING TOP	30 [hp_X]  in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	30 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_X]  in 1 mL
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC CHLORIDE	30 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	30 [hp_X]  in 1 mL
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	30 [hp_X]  in 1 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	30 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_X]  in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	30 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786)	THUJA OCCIDENTALIS LEAF	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: 43857-0224-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/20/2013	07/02/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/20/2013	07/02/2019

Labeler - BioActive Nutritional (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0224) , api manufacture(43857-0224) , label(43857-0224) , pack(43857-0224)

Revised: 8/2016

Document Id: efde31a8-2068-47dc-a754-0531ea093aa9

Set id: 83e476fa-2e8d-4aca-9e9e-568f0fae5432

Version: 2

Effective Time: 20160825