Search by Drug Name or NDC

NDC 17089-0466-18 GUNA DEEP CLEANSE 12; 3; 4; 6; 3; 6; 4; 2; 4; 4; 6; 12; 12; 4; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA DEEP CLEANSE 12; 3; 4; 6; 3; 6; 4; 2; 4; 4; 6; 12; 12; 4; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

GUNA DEEP CLEANSE is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS ROOT; CHONDRODENDRON TOMENTOSUM ROOT; EQUISETUM HYEMALE WHOLE; FUCUS VESICULOSUS; GALIUM APARINE WHOLE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LYCOPODIUM CLAVATUM SPORE; MYOSOTIS ARVENSIS; .

Product Information

NDC	17089-0466
Product ID	17089-466_af5e38c0-3d5d-4733-e053-2a95a90afefe
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	GUNA DEEP CLEANSE
Proprietary Name Suffix	n/a
Non-Proprietary Name	apis mellifera - berberis vulgaris root bark - chelidonium majus - chondrodendron tomentosum root - equisetum hyemale whole - fucus vesiculosus - galium aparine whole - hamamelis virginiana root bark - lycopodium clavatum spore - myosotis arvensis - podop
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	12; 3; 4; 6; 3; 6; 4; 2; 4; 4; 6; 12; 12; 4; 4; 6
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS ROOT; CHONDRODENDRON TOMENTOSUM ROOT; EQUISETUM HYEMALE WHOLE; FUCUS VESICULOSUS; GALIUM APARINE WHOLE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LYCOPODIUM CLAVATUM SPORE; MYOSOTIS ARVENSIS;
Labeler Name	Guna spa
Pharmaceutical Class	Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large In
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0466-18 (17089046618)

Pricing Information	N/A
NDC Package Code	17089-466-18
Billing NDC	17089046618
Package	1 BOTTLE, DROPPER in 1 BOX (17089-466-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-09-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL af5e3933-4b2f-0966-e053-2995a90aaf2c Details

SPL UNCLASSIFIED SECTION

Helps drain toxins and liquids,

supports kidney and liver cleansing function

Purpose

Helps drain toxins and liquids,

supports kidney and liver cleansing function

Active Ingredient(s)

Apis mellifica 12X Relieves swelling

Berberis vulgaris 3X Supports liver and kidney drainage

Chelidonoium majus 4X Supports liver and gallbladder function

Equisetum hyemale 3X Supports kidney and bladder drainage

Fucus vesiculosus 6X Supports detoxification

Galium aparine 4X Increases urination

Hamamelis 2X Improves blood circulation

Lycopodium clavatum 4X Supports liver function and drainage

Myosotis arvensis 4X Supports detoxification

Natrum sulphuricum 12X Supports detoxification

Nux vomica 4X Relieves constipation

Pareira brava 6X Relieves urinary discomfort

Podophyllum peltatum 6X Supports bowel regularity

Pyrogenium 12X Supports detoxification

Solidago 4X Supports liver and kidney function

Thuja occidentalis 6X Supports detoxification

SPL UNCLASSIFIED SECTION

Take 15 minutes before meals

Warnings

Warnings:

Stop use and ask doctor if symptoms persist more than 5 days.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children.
In case of accidental overdose, seek prfessional assistance or contact a Poison Control Center immediately
Contains ethyl alcohol 30%

Do not use

if tamper-evident seal is broken

SPL UNCLASSIFIED SECTION

Stop use and ask doctor if symptoms persist more than 5 days.

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

Directions

Take 15 minutes before meals.

Adults and children twelve years and older: 20 drops in a little water, 2 times per day

Children between 12 years and 6 years of age: 10 drops in a little water, 2 times per day

Children under 6 years: consult a physician

Other information

No special storage conditions

Inactive ingredients

Inactive Ingredient: Ethyl alcohol 30%

SPL UNCLASSIFIED SECTION

To Report SUSPECTED ADVERSE REACTIONS, contact Guna Inc at (484) 223-3500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

GUNA DEEP CLEANSE

apis mellifera - berberis vulgaris root bark - chelidonium majus - chondrodendron tomentosum root - equisetum hyemale whole - fucus vesiculosus - galium aparine whole - hamamelis virginiana root bark - lycopodium clavatum spore - myosotis arvensis - podophyllum peltatum root - rancid beef - sodium sulfate - solidago virgaurea flowering top - strychnos nux vomica seed - thuja occidentalis leafy twig - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-466
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHELIDONIUM MAJUS ROOT (UNII: FLT36UCF0N) (CHELIDONIUM MAJUS ROOT - UNII:FLT36UCF0N)	CHELIDONIUM MAJUS ROOT	4 [hp_X] in 30 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	4 [hp_X] in 30 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM SULFATE	12 [hp_X] in 30 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	4 [hp_X] in 30 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	12 [hp_X] in 30 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	6 [hp_X] in 30 mL
GALIUM APARINE WHOLE (UNII: Z4B6561488) (GALIUM APARINE WHOLE - UNII:Z4B6561488)	GALIUM APARINE WHOLE	4 [hp_X] in 30 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	6 [hp_X] in 30 mL
MYOSOTIS ARVENSIS (UNII: C73BK97H5J) (MYOSOTIS ARVENSIS - UNII:C73BK97H5J)	MYOSOTIS ARVENSIS	4 [hp_X] in 30 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	4 [hp_X] in 30 mL
PODOPHYLLUM PELTATUM ROOT (UNII: 2S713A4VP3) (PODOPHYLLUM PELTATUM ROOT - UNII:2S713A4VP3)	PODOPHYLLUM PELTATUM ROOT	6 [hp_X] in 30 mL
CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z)	CHONDRODENDRON TOMENTOSUM ROOT	6 [hp_X] in 30 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	12 [hp_X] in 30 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	3 [hp_X] in 30 mL
EQUISETUM HYEMALE WHOLE (UNII: 59677RXH25) (EQUISETUM HYEMALE WHOLE - UNII:59677RXH25)	EQUISETUM HYEMALE WHOLE	3 [hp_X] in 30 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	2 [hp_X] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)	9 mL in 30 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-466-18	1 in 1 BOX	09/24/2020
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		09/24/2020

Labeler - Guna spa (430538264)

Registrant - GUNA Spa (338587646)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-466)

Revised: 9/2020

Document Id: af5e38c0-3d5d-4733-e053-2a95a90afefe

Set id: af5e3933-4b2f-0966-e053-2995a90aaf2c

Version: 1

Effective Time: 20200924

Search by Drug Name or NDC

NDC 17089-0466-18 GUNA DEEP CLEANSE 12; 3; 4; 6; 3; 6; 4; 2; 4; 4; 6; 12; 12; 4; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA DEEP CLEANSE 12; 3; 4; 6; 3; 6; 4; 2; 4; 4; 6; 12; 12; 4; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

Product Information

Package

Package Images

NDC 17089-0466-18 (17089046618)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL af5e3933-4b2f-0966-e053-2995a90aaf2c Details

SPL UNCLASSIFIED SECTION

Purpose

Active Ingredient(s)

SPL UNCLASSIFIED SECTION

Warnings

Do not use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

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