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NDC 17089-0462-18 GUNA LYMPHO DETOX 8; 1; 2; 6; 3; 6; 5; 12; 2; 5; 12; 12; 6; 4; 4; 3; 6; 6; 6; 1 [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; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/3 Details

GUNA LYMPHO DETOX 8; 1; 2; 6; 3; 6; 5; 12; 2; 5; 12; 12; 6; 4; 4; 3; 6; 6; 6; 1 [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; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/3

GUNA LYMPHO DETOX 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; CALENDULA OFFICINALIS FLOWER; CENTELLA ASIATICA WHOLE; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; EQUISETUM HYEMALE; FUMARIC ACID; GOLDENSEAL; GRAPHITE; HORSE CHESTNUT; JUGLANS REGIA FRUIT RIND, IMMATURE; LEVOTHYROXINE; MAGNESIUM PHOSPHATE, DIBAS.

Product Information

NDC	17089-0462
Product ID	17089-462_b2588f62-6cc5-327e-e053-2a95a90aaafb
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 LYMPHO DETOX
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aesculus hippocastanum - apis mellifera - calendula officinalis flower - hexaketocyclohexane - equisetum hyemale - fumaric acid - graphite - hydrastis canadensis - hydrocotyle asiatica - juglans regia - levothyroxine - magnesium phosphate - malic acid - m
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	8; 1; 2; 6; 3; 6; 5; 12; 2; 5; 12; 12; 6; 4; 4; 3; 6; 6; 6; 1
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; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/3
Substance Name	APIS MELLIFERA; CALENDULA OFFICINALIS FLOWER; CENTELLA ASIATICA WHOLE; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; EQUISETUM HYEMALE; FUMARIC ACID; GOLDENSEAL; GRAPHITE; HORSE CHESTNUT; JUGLANS REGIA FRUIT RIND, IMMATURE; LEVOTHYROXINE; MAGNESIUM PHOSPHATE, DIBAS
Labeler Name	Guna spa
Pharmaceutical Class	Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorpti
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0462-18 (17089046218)

Pricing Information	N/A
NDC Package Code	17089-462-18
Billing NDC	17089046218
Package	1 BOTTLE, DROPPER in 1 BOX (17089-462-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-09-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aeb71e21-2fdb-6b84-e053-2995a90a4c01 Details

DIRECTIONS

Adults and children 12 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

ACTIVE INGREDIENTS/PURPOSE

AESCULUS HIPPOCASTANUM 2X HELPS VENOUS FLOW

CALENDULA OFFICINALIS 1X HELPS REDUCE SWELLING

TARAXACUM OFFICINALE 1X PROMOTES URINATION

APIS MELLIFICA 8X HELPS REDUCE SWELLING

EQUISETUM HYEMALE 3X PROMOTES URINATION

FUMARICUM ACIDUM 6X PROMOTES URINATION

GRAPHITES 12X 30X 200X DETOXIFICATION

JUGLANS REGIA 5X DETOXIFICATION

LEVOTHYROXINUM 12X HELPS REDUCE SWELLING

MAGNESIA PHOSPHORICA 12X 30X 200X DETOXIFICATION

MALICUM ACIDUM 6X DETOXIFICATION

MYOSOTIS ARVENSIS 4X RELIEVES SWOLLEN LYMPH NODES, INFLAMED TONSILS

NATRUM OXALACETICUM 6X DETOXIFICATION

NATRUM PYRUVICUM 6X DETOXIFICATION

PHYTOLACCA DECANDRA 4X RELIEVES SWOLLEN LYMPH NODES, INFLAMED TONSILS

PLACENTA TOTALIS SUIS 6X SUPPORTS CIRCULATION

SARSAPARILLA 3X RELIEVES SWOLLEN LYMPH NODES

TRICHINOYL PHOSPHATE 6X RELIEVES SWOLLEN LYMPH NODES

HYDRASTIS CANADENSIS 5X RELIEVES SORE THROAT

HYDROCOTYLE ASIATICA 2X RELIEVES SORE THROAT

USES

Helps eliminate toxins, temporarily relieves symptoms of poor lymphatic circulation, such as:

swollen legs
swollen lymph nodes
inflamed tonsils, sore throat

WARNINGS

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

PREGNANCY

If pregnant or breast-feeding ask a health care professional before use

WARNINGS

Keep out of reach of children

QUESTIONS

Questions?: [email protected]

(484) 223-3500

SPL UNCLASSIFIED SECTION

Take 15 minutes before meals

SPL UNCLASSIFIED SECTION

Inactive ingredient: Ethyl alcohol 30%.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA LYMPHO DETOX

aesculus hippocastanum - apis mellifera - calendula officinalis flower - hexaketocyclohexane - equisetum hyemale - fumaric acid - graphite - hydrastis canadensis - hydrocotyle asiatica - juglans regia - levothyroxine - magnesium phosphate - malic acid - myosotis arvensis - phytolacca americana root - sarsaparilla - sodium diethyl oxalacetate - sodium pyruvate - sus scrofa placenta - taraxacum officinale - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-462
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	8 [hp_X] in 30 mL
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X] in 30 mL
MALIC ACID (UNII: 817L1N4CKP) (MALIC ACID - UNII:817L1N4CKP)	MALIC ACID	6 [hp_X] in 30 mL
EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25)	EQUISETUM HYEMALE	3 [hp_X] in 30 mL
FUMARIC ACID (UNII: 88XHZ13131) (FUMARIC ACID - UNII:88XHZ13131)	FUMARIC ACID	6 [hp_X] in 30 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	12 [hp_X] in 30 mL
JUGLANS REGIA FRUIT RIND, IMMATURE (UNII: ZPS7Q5U53K) (JUGLANS REGIA FRUIT RIND, IMMATURE - UNII:ZPS7Q5U53K)	JUGLANS REGIA FRUIT RIND, IMMATURE	5 [hp_X] in 30 mL
LEVOTHYROXINE (UNII: Q51BO43MG4) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	12 [hp_X] in 30 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	12 [hp_X] in 30 mL
MYOSOTIS ARVENSIS (UNII: C73BK97H5J) (MYOSOTIS ARVENSIS - UNII:C73BK97H5J)	MYOSOTIS ARVENSIS	4 [hp_X] in 30 mL
SODIUM DIETHYL OXALACETATE (UNII: 6CA025Y4FG) (DIETHYL OXALACETATE - UNII:15S56468G7)	SODIUM DIETHYL OXALACETATE	6 [hp_X] in 30 mL
SODIUM PYRUVATE (UNII: POD38AIF08) (PYRUVIC ACID - UNII:8558G7RUTR)	SODIUM PYRUVATE	6 [hp_X] in 30 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	4 [hp_X] in 30 mL
SARSAPARILLA (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SARSAPARILLA	3 [hp_X] in 30 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	1 [hp_X] in 30 mL
DODECAHYDROXYCYCLOHEXANE DIHYDRATE (UNII: 5BWD2J7B4W) (DODECAHYDROXYCYCLOHEXANE - UNII:I1Z9VS3H64)	DODECAHYDROXYCYCLOHEXANE DIHYDRATE	6 [hp_X] in 30 mL
SUS SCROFA PLACENTA (UNII: C8CV8867O8) (SUS SCROFA PLACENTA - UNII:C8CV8867O8)	SUS SCROFA PLACENTA	6 [hp_X] in 30 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	2 [hp_X] in 30 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	5 [hp_X] in 30 mL
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) (CENTELLA ASIATICA WHOLE - UNII:7M867G6T1U)	CENTELLA ASIATICA WHOLE	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:17089-462-18	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)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-462)

Revised: 10/2020

Document Id: b2588f62-6cc5-327e-e053-2a95a90aaafb

Set id: aeb71e21-2fdb-6b84-e053-2995a90a4c01

Version: 2

Effective Time: 20201023

Search by Drug Name or NDC

Product Information

Package

Package Images

NDC 17089-0462-18 (17089046218)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL aeb71e21-2fdb-6b84-e053-2995a90a4c01 Details

DIRECTIONS

ACTIVE INGREDIENTS/PURPOSE

USES

WARNINGS

PREGNANCY

WARNINGS

QUESTIONS

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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