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NDC 17089-0460-18 GUNA MATRIX DETOX 3; 6; 4; 12; 6; 4; 12; 8; 3; 3; 12; 2; 6; 6; 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 Details

GUNA MATRIX DETOX 3; 6; 4; 12; 6; 4; 12; 8; 3; 3; 12; 2; 6; 6; 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

GUNA MATRIX DETOX is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is CONIUM MACULATUM FLOWERING TOP; FUCUS VESICULOSUS; GALIUM APARINE WHOLE; GRAPHITE; MALIC ACID; MYOSOTIS ARVENSIS; RANCID BEEF; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA VEIN;.

Product Information

NDC	17089-0460
Product ID	17089-460_b2587436-faab-37c8-e053-2995a90a3fba
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 MATRIX DETOX
Proprietary Name Suffix	n/a
Non-Proprietary Name	sodium sulfate - podophyllum peltatum root - solidago virgaurea flowering top - apis mellifera - equisetum hyemale - strychnos nux vomica seed - hamamelis virginiana root bark stem bark - lycopodium clavatum spore - galium aparine whole - thuja occidental
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	3; 6; 4; 12; 6; 4; 12; 8; 3; 3; 12; 2; 6; 6; 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
Substance Name	CONIUM MACULATUM FLOWERING TOP; FUCUS VESICULOSUS; GALIUM APARINE WHOLE; GRAPHITE; MALIC ACID; MYOSOTIS ARVENSIS; RANCID BEEF; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA VEIN;
Labeler Name	Guna spa
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0460-18 (17089046018)

Pricing Information	N/A
NDC Package Code	17089-460-18
Billing NDC	17089046018
Package	1 BOTTLE, DROPPER in 1 BOX (17089-460-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-07-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a369b95b-4d57-f149-e053-2995a90a87e3 Details

Active Ingredient(s)

Active ingredient Purpose

Conium maculatum 3X relieves fatigue

Fucus vesiculosus 6X detoxification

Galium aparine 4X increases urination

Graphites 12X relieves skin rashes

Malicum acidum 6X detoxification

Myosotis arvensis 4X helps venous and lymphatic flow

Natrum oxalaceticum 3X relieves skin rashes

Natrum pyruvicum 3X relieves skin rashes

Natrum sulphuricum 12X detoxification

Pyrogenium 12X detoxification

Solidago virgaurea 2X helps kidney function

Thuja occidentalis 6X detoxification

Urtica urens 6X detoxification

Vena suis 6X helps venous and lymphatic flow

Silicea 8X relieves fatigue

Purpose

HELPS ELIMINATE TOXINS, RELIEVES SYMPTOMS OF TOXIN BUILDUP, SUCH AS:

Fatigue
Skin rashes
Swelling

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

helps eliminate toxins, relieves symptoms of toxin buildup, such as: fatigue, skin rashes, swelling.

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 MATRIX DETOX

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-460
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	6 [hp_X] in 30 mL
SUS SCROFA VEIN (UNII: 2510RH3I89) (SUS SCROFA VEIN - UNII:2510RH3I89)	SUS SCROFA VEIN	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
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	3 [hp_X] in 30 mL
MYOSOTIS ARVENSIS (UNII: C73BK97H5J) (MYOSOTIS ARVENSIS - UNII:C73BK97H5J)	MYOSOTIS ARVENSIS	4 [hp_X] in 30 mL
SODIUM PYRUVATE (UNII: POD38AIF08) (PYRUVIC ACID - UNII:8558G7RUTR)	SODIUM PYRUVATE	3 [hp_X] in 30 mL
MALIC ACID (UNII: 817L1N4CKP) (MALIC ACID - UNII:817L1N4CKP)	MALIC ACID	6 [hp_X] in 30 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	12 [hp_X] in 30 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	8 [hp_X] in 30 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM SULFATE	12 [hp_X] in 30 mL
SODIUM DIETHYL OXALACETATE (UNII: 6CA025Y4FG) (DIETHYL OXALACETATE - UNII:15S56468G7)	SODIUM DIETHYL OXALACETATE	3 [hp_X] in 30 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	2 [hp_X] in 30 mL
URTICA URENS WHOLE (UNII: IHN2NQ5OF9) (URTICA URENS WHOLE - UNII:IHN2NQ5OF9)	URTICA URENS WHOLE	6 [hp_X] in 30 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	12 [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:17089-460-18	1 in 1 BOX	07/14/2020
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		07/14/2020

Labeler - Guna spa (430538264)

Registrant - GUNA Spa (338587646)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-460)

Revised: 10/2020

Document Id: b2587436-faab-37c8-e053-2995a90a3fba

Set id: a369b95b-4d57-f149-e053-2995a90a87e3

Version: 2

Effective Time: 20201023

Search by Drug Name or NDC

NDC 17089-0460-18 GUNA MATRIX DETOX 3; 6; 4; 12; 6; 4; 12; 8; 3; 3; 12; 2; 6; 6; 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 Details

GUNA MATRIX DETOX 3; 6; 4; 12; 6; 4; 12; 8; 3; 3; 12; 2; 6; 6; 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

Product Information

Package

Package Images

NDC 17089-0460-18 (17089046018)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a369b95b-4d57-f149-e053-2995a90a87e3 Details

Active Ingredient(s)

Purpose

SPL UNCLASSIFIED SECTION

Warnings

Do not use

SPL UNCLASSIFIED SECTION

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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