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 spa

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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GUNA-PROSTATE

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: Ethyl alcohol 30%.

Take 15 minutes before meals.

indications and usage section

PRINCIPAL DISPLAY PANEL

5USPRO-REV10-040418 GUNA PROSTATE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2017

Labeler - Guna spa (430538264)

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