PROSTATONE- echinacea, hydrastis canadensis, phytolacca decandra, sabal serrulata, sarsaparilla, solidago virgaurea 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 3X, Hydrastis Canadensis 3X, Phytolacca Decandra 3X, Sabal Serrulata 3X, Sarsaparilla 3X, Solidago Virgaurea 3X, Zincum Sulphuricum 3X, Orchitinum (Suis) 8X, Prostate 8X, Clematis Erecta 12X, Phosphoricum Acidum 12X, Pulsatilla 12X

INDICATIONS

For temporary relief of pain in the scrotum, testicles tender and swollen.

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.

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.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS AND USAGE

For temporary relief of pain in the scrotum, testicles tender and swollen.

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

PROSTATONE

1 FL OZ (30 ml)

Prostatone

PROSTATONE
echinacea, hydrastis canadensis, phytolacca decandra, sabal serrulata, sarsaparilla, solidago virgaurea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0137
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	3 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [hp_X] in 1 mL
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	3 [hp_X] in 1 mL
SMILAX REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SMILAX REGELII ROOT	3 [hp_X] in 1 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	3 [hp_X] in 1 mL
ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3 [hp_X] in 1 mL
SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28)	SUS SCROFA TESTICLE	8 [hp_X] in 1 mL
SUS SCROFA PROSTATE (UNII: O6UD3347K2) (SUS SCROFA PROSTATE - UNII:O6UD3347K2)	SUS SCROFA PROSTATE	8 [hp_X] in 1 mL
CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F)	CLEMATIS RECTA FLOWERING TOP	12 [hp_X] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	12 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	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:43857-0137-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/27/2013	08/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/27/2013	08/25/2020

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0137) , api manufacture(43857-0137) , label(43857-0137) , pack(43857-0137)

Revised: 2/2018

Document Id: 85ac187a-e130-4480-811a-cdb85fc1639a

Set id: 2ea83275-63d5-47cd-aabe-7a4a39b9e96f

Version: 2

Effective Time: 20180228

BioActive Nutritional, Inc.