Prostatone

Manufacturer: BioActive Nutritional, Inc. | Apotheca Company
Effective date: 2018-02-28
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:02:49

Label at a glance#

ProductProstatone

Active ingredientECHINACEA, UNSPECIFIED, GOLDENSEAL, PHYTOLACCA AMERICANA ROOT, SAW PALMETTO, SMILAX REGELII ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ZINC SULFATE HEPTAHYDRATE, SUS SCROFA TESTICLE, SUS SCROFA PROSTATE, CLEMATIS RECTA FLOWERING TOP, PHOSPHORIC ACID, PULSATILLA VULGARIS

Label structure9 sections

Indications and uses

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

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

WARNINGS

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

QUESTIONS

OTC - QUESTIONS SECTION

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Homeopathic

PROSTATONE

1 FL OZ (30 ml)

Prostatone

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CLEMATIS RECTA FLOWERING TOP	ACTIVE INGREDIENT	396421SP9F	1
ECHINACEA, UNSPECIFIED	ACTIVE INGREDIENT	4N9P6CC1DX	1
GOLDENSEAL	ACTIVE INGREDIENT	ZW3Z11D0JV	1
PHOSPHORIC ACID	ACTIVE INGREDIENT	E4GA8884NN	1
PHYTOLACCA AMERICANA ROOT	ACTIVE INGREDIENT	11E6VI8VEG	1
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	1
SAW PALMETTO	ACTIVE INGREDIENT	J7WWH9M8QS	1
SMILAX REGELII ROOT	ACTIVE INGREDIENT	2H1576D5WG	1
SOLIDAGO VIRGAUREA FLOWERING TOP	ACTIVE INGREDIENT	5405K23S50	1
SUS SCROFA PROSTATE	ACTIVE INGREDIENT	O6UD3347K2	1
SUS SCROFA TESTICLE	ACTIVE INGREDIENT	KM02613O28	1
ZINC SULFATE HEPTAHYDRATE	ACTIVE INGREDIENT	N57JI2K7WP	1
CLEMATIS RECTA FLOWERING TOP	ACTIVE MOIETY	396421SP9F	1
ECHINACEA, UNSPECIFIED	ACTIVE MOIETY	4N9P6CC1DX	1
GOLDENSEAL	ACTIVE MOIETY	ZW3Z11D0JV	1
PHOSPHORIC ACID	ACTIVE MOIETY	E4GA8884NN	1
PHYTOLACCA AMERICANA ROOT	ACTIVE MOIETY	11E6VI8VEG	1
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	1
SARSAPARILLA	ACTIVE MOIETY	2H1576D5WG	1
SAW PALMETTO	ACTIVE MOIETY	J7WWH9M8QS	1
SOLIDAGO VIRGAUREA FLOWERING TOP	ACTIVE MOIETY	5405K23S50	1
SUS SCROFA PROSTATE	ACTIVE MOIETY	O6UD3347K2	1
SUS SCROFA TESTICLE	ACTIVE MOIETY	KM02613O28	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

Prostatone
Echinacea, Hydrastis Canadensis, Phytolacca Decandra, Sabal Serrulata, Sarsaparilla, Solidago Virgaurea
ECHINACEA, UNSPECIFIED
GOLDENSEAL
PHYTOLACCA AMERICANA ROOT
SAW PALMETTO
SMILAX REGELII ROOT
SARSAPARILLA
SOLIDAGO VIRGAUREA FLOWERING TOP
ZINC SULFATE HEPTAHYDRATE
ZINC CATION
SUS SCROFA TESTICLE
SUS SCROFA PROSTATE
CLEMATIS RECTA FLOWERING TOP
PHOSPHORIC ACID
PULSATILLA VULGARIS
WATER
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43857-0137	43857-0137-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ECHINACEA, UNSPECIFIED	4N9P6CC1DX	ACTIB
GOLDENSEAL	ZW3Z11D0JV	ACTIB
PHYTOLACCA AMERICANA ROOT	11E6VI8VEG	ACTIB
SAW PALMETTO	J7WWH9M8QS	ACTIB
SMILAX REGELII ROOT	2H1576D5WG	ACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP	5405K23S50	ACTIB
ZINC SULFATE HEPTAHYDRATE	N57JI2K7WP	ACTIM
SUS SCROFA TESTICLE	KM02613O28	ACTIB
SUS SCROFA PROSTATE	O6UD3347K2	ACTIB
CLEMATIS RECTA FLOWERING TOP	396421SP9F	ACTIB
PHOSPHORIC ACID	E4GA8884NN	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
85ac187a-e130-4480-811a-cdb85fc1639a			2ea83275-63d5-47cd-aabe-7a4a39b9e96f	2018-02-28	Warnings	Exact identifier spl id: 85ac187a-e130-4480-811a-cdb85fc1639a spl set id: 2ea83275-63d5-47cd-aabe-7a4a39b9e96f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.