GUNA-PROSTATE (aldesleukin - barium carbonate - chaste tree - chimaphila umbellata - clematis vitalba - conium maculatum flowering top - delphinium staphisagria seed - digitalis - ferric picrate - human interleukin-10- nonglycosylated - interferon gamma-1b - melatonin - saw palmetto - selenium - sus scrofa prostate - thuja occidentalis twig - transforming growth factor beta-1 - zinc - solution/ drops

GUNA-PROSTATE by

Drug Labeling and Warnings

GUNA-PROSTATE by is a Homeopathic medication manufactured, distributed, or labeled by Guna spa. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS/PURPOSE

AGNUS CASTUS        6X    INCONTINENCE
BARYTA CARBONICA    12X 30X    PAINFUL URINATION
CHIMAPHILA UMBELLATA    6X    DETOXIFICATION
CLEMATIS ERECTA        3X    ANTIOXIDANT
CONIUM MACULATUM    12X 30X    ANTIOXIDANT
DIGITALIS PURPUREA    12X 30X    RELIEVES URINARY IRRITATION
FERRUM PICRINICUM    12X 30X    SUDDEN URGE TO URINATE
INTERFERON GAMMA    4C    ANTIOXIDANT
INTERLEUKIN 10        4C    PAINFUL URINATION
INTERLEUKIN 2        4C    PAINFUL URINATION
MELATONIN        4C    HORMONAL REGULATION
PROSTATE        200X    PAINFUL URINATION
SABAL SERRULATA        3X    PAINFUL URINATION
SELENIUM METALLICUM    12X 30X    SLOWED START OF URINATION
STAPHYSAGRIA        12X 30X    PAINFUL URINATION
TGF BETA        4C    PAINFUL URINATION
THUJA OCCIDENTALIS    12X 30X    SLOWED START OF URINATION
ZINCUM METALLICUM    3X    SLOWED START OF URINATION

USES

Temporary relief of symptoms such as:

• Urinary disconfort, hesitancy, frequency
• Slow or painful urination

WARNINGS

• Stop use and ask doctor if symptoms persist more than 5 days or worsen.
• If pregnant or breast-feeding ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• Contains ethyl alcohol 30%

PREGNANCY

If pregnant or breast-feeding ask a doctor before use

WARNINGS

Keep out of reach of children

DIRECTIONS

Directions:

Take 15 minutes before meals

Adults: 20 drops in a little water, 2 times per day

QUESTIONS

Questions?: info@gunainc.com, tel. (484) 223-3500

INACTIVE INGREDIENT

Inactive ingredient: Ethyl alcohol 30%.

INDICATIONS & USAGE

• Take 15 minutes before meals.

INDICATIONS & USAGE

• indications and usage section

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA-PROSTATE 
aldesleukin - barium carbonate - chaste tree - chimaphila umbellata - clematis vitalba - conium maculatum flowering top - delphinium staphisagria seed - digitalis - ferric picrate - human interleukin-10 (nonglycosylated) - interferon gamma-1b - melatonin - saw palmetto - selenium - sus scrofa prostate - thuja occidentalis twig - transforming growth factor beta-1 - zinc - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17089-346
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERRIC PICRATE (UNII: KZM8ZRY36A) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	30 [hp_X]  in 30 mL
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A)	CHASTE TREE	6 [hp_X]  in 30 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN)	BARIUM CARBONATE	30 [hp_X]  in 30 mL
CHIMAPHILA UMBELLATA (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA - UNII:WCK21A9W9J)	CHIMAPHILA UMBELLATA	6 [hp_X]  in 30 mL
CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F)	CLEMATIS RECTA FLOWERING TOP	3 [hp_X]  in 30 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	30 [hp_X]  in 30 mL
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B)	DIGITALIS	30 [hp_X]  in 30 mL
INTERFERON GAMMA-1B (UNII: 21K6M2I7AG) (INTERFERON GAMMA-1B - UNII:21K6M2I7AG)	INTERFERON GAMMA-1B	4 [hp_C]  in 30 mL
INTERLEUKIN-10 (UNII: 9SC4O216V9) (INTERLEUKIN-10 - UNII:9SC4O216V9)	INTERLEUKIN-10	4 [hp_C]  in 30 mL
ALDESLEUKIN (UNII: M89N0Q7EQR) (ALDESLEUKIN - UNII:M89N0Q7EQR)	ALDESLEUKIN	4 [hp_C]  in 30 mL
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	4 [hp_C]  in 30 mL
SUS SCROFA PROSTATE (UNII: O6UD3347K2) (SUS SCROFA PROSTATE - UNII:O6UD3347K2)	SUS SCROFA PROSTATE	200 [hp_X]  in 30 mL
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	3 [hp_X]  in 30 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	30 [hp_X]  in 30 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	30 [hp_X]  in 30 mL
TRANSFORMING GROWTH FACTOR BETA-1 (UNII: T7D25J14LT) (TRANSFORMING GROWTH FACTOR BETA-1 - UNII:T7D25J14LT)	TRANSFORMING GROWTH FACTOR BETA-1	4 [hp_C]  in 30 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	30 [hp_X]  in 30 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	3 [hp_X]  in 30 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17089-346-18	1 in 1 BOX	12/21/2018
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2017

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Business Operations
Guna spa		338587646	manufacture(17089-346)