Male Vitality T021 (Damiana, Korean Ginseng, Populus Tremuloides, Nuphar Luteum, Arnica Montana, Carduus Marianus, Galium Aparine, Lactuca Virosa, Caladium Seguinum, Hepar Suis, Orchitinum (S -

MALE VITALITY T021 (DAMIANA, KOREAN GINSENG, POPULUS TREMULOIDES, NUPHAR LUTEUM, ARNICA MONTANA, CARDUUS MARIANUS, GALIUM APARINE, LACTUCA VIROSA, CALADIUM SEGUINUM, HEPAR SUIS, ORCHITINUM (S
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NDC	71742-0015-1
Set ID	7a481349-bf0e-4cb3-8567-a36c9568837b
Category	HUMAN OTC DRUG LABEL
Packager	Guangzhou Renuma Medical Systems Co., Ltd
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENTS:

Damiana 1X, Korean Ginseng 1X, Populus Tremuloides 1X, Nuphar Luteum 2X, Arnica Montana 3X, Carduus Marianus 3X, Galium Aparine 3X, Lactuca Virosa 3X, Caladium Seguinum 6X, Hepar Suis 6X, Orchitinum (Suis) 6X, Thymus (Suis) 6X, Glandula Suprarenalis Suis 12X, Hypophysis Suis 12X, Thyroidinum (Suis) 12X, Testosterone 30X, Phosphoricum Acidum 200C, Thuja Occidentalis 200C.
INDICATIONS:

May temporarily relieve symptoms of occasional low male sexual energy, which may include decrease in sexual desire, performance and enjoyment, as well as feelings of fatigue.
WARNINGS:

If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in cool, dry place.
KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DIRECTIONS:

Adults only: 7 drops 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional.
INDICATIONS:

May temporarily relieve symptoms of occasional low male sexual energy, which may include decrease in sexual desire, performance and enjoyment, as well as feelings of fatigue.
INACTIVE INGREDIENTS:

Demineralized Water, 10% Ethanol, Glycerin.
QUESTIONS:

Distributed by:
Guangzhou Renuma Medical
Systems Co., Ltd.
No. 5, 2nd Floor, Ascendas 2nd Street
Sino-Singapore Guangzhou Knowledge City
Guangzhou 510555, China
PACKAGE LABEL DISPLAY:

MALE

VITALITY

T021

HOMEOPATHIC

2 fl. oz. (59 ml)

INGREDIENTS AND APPEARANCE

MALE VITALITY T021
damiana, korean ginseng, populus tremuloides, nuphar luteum, arnica montana, carduus marianus, galium aparine, lactuca virosa, caladium seguinum, hepar suis, orchitinum (suis), thymus (suis), glandula suprarenalis suis, hypophysis suis, thyroidinum (suis), testosterone, phosphoricum acidum, thuja occidentalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71742-0015
Route of Administration	ORAL	DEA Schedule	CIII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ)	TURNERA DIFFUSA LEAFY TWIG	1 [hp_X] in 1 mL
ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI)	ASIAN GINSENG	1 [hp_X] in 1 mL
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) (POPULUS TREMULOIDES BARK - UNII:5543O0CEID)	POPULUS TREMULOIDES BARK	1 [hp_X] in 1 mL
NUPHAR LUTEA ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEA ROOT - UNII:714LIU3V6D)	NUPHAR LUTEA ROOT	2 [hp_X] in 1 mL
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW)	ARNICA MONTANA WHOLE	3 [hp_X] in 1 mL
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	3 [hp_X] in 1 mL
GALIUM APARINE WHOLE (UNII: Z4B6561488) (GALIUM APARINE WHOLE - UNII:Z4B6561488)	GALIUM APARINE WHOLE	3 [hp_X] in 1 mL
LACTUCA VIROSA WHOLE (UNII: 6D74QW4H67) (LACTUCA VIROSA WHOLE - UNII:6D74QW4H67)	LACTUCA VIROSA WHOLE	3 [hp_X] in 1 mL
DIEFFENBACHIA SEGUINE WHOLE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE WHOLE - UNII:01800C6E6B)	DIEFFENBACHIA SEGUINE WHOLE	6 [hp_X] in 1 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	6 [hp_X] in 1 mL
SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28)	SUS SCROFA TESTICLE	6 [hp_X] in 1 mL
SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62)	SUS SCROFA THYMUS	6 [hp_X] in 1 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	12 [hp_X] in 1 mL
SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT)	SUS SCROFA PITUITARY GLAND	12 [hp_X] in 1 mL
THYROID, PORCINE (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ)	THYROID, PORCINE	12 [hp_X] in 1 mL
TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)	TESTOSTERONE	30 [hp_X] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	200 [hp_C] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	200 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71742-0015-1	59 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/31/2017

Labeler - Guangzhou Renuma Medical Systems Co., Ltd (544538706)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(71742-0015) , api manufacture(71742-0015) , label(71742-0015) , pack(71742-0015)

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