TESTOSTERONE (avena sativa, carduus marianus, damiana, galium aparine, hamamelis virginiana, hepar bovine, korean ginseng, nuphar luteum, orchitinum- bovine, populus tremuloides, testosterone, thuja occidentalis liquid

Testosterone by

Drug Labeling and Warnings

Testosterone by is a Homeopathic medication manufactured, distributed, or labeled by ProBLEN, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Avena Sativa 1X, Carduus Marianus 1X, Damiana 1X, Galium Aparine 3X, Hamamelis Virginiana 1X, Hepar Bovine 6X, Korean Ginseng 1X, Nuphar Luteum 2X, Orchitinum (Bovine) 6X, Populus Tremuloides 1X, Testosterone 30X, Thuja Occidentalis 200C.

INDICATIONS:

Temporarily supports the body to rebalance testosterone output. Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

WARNINGS:

Not for use on children. If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness. As with all medicines, ​if you are pregnant or breast feeding,​ consult a health professional before using this product. ​Keep out of the reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.

Tamper Evident: There is a seal around the neck of the bottle. Do not use if this seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.

INDICATIONS:

Temporarily supports the body to rebalance testosterone output. Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

INACTIVE INGREDIENTS:

Purified Water, Organic Ethanol 30%

QUESTIONS:

Distributed By ProBLEN

2850 Shoreline Trail

Rockwall, TX 75032

www.problen.com

PACKAGE LABEL DISPLAY:

Testosterone

HOMEOPATHIC

ORGANOTHERAPY

1.0 FL OZ (30 ML)

proBLEN

INGREDIENTS AND APPEARANCE

TESTOSTERONE 
avena sativa, carduus marianus, damiana, galium aparine, hamamelis virginiana, hepar bovine, korean ginseng, nuphar luteum, orchitinum (bovine), populus tremuloides, testosterone, thuja occidentalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43853-0005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	1 [hp_X]  in 1 mL
SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE)	SILYBUM MARIANUM SEED	1 [hp_X]  in 1 mL
TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ)	TURNERA DIFFUSA LEAFY TWIG	1 [hp_X]  in 1 mL
GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488)	GALIUM APARINE	3 [hp_X]  in 1 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	1 [hp_X]  in 1 mL
BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022)	BEEF LIVER	6 [hp_X]  in 1 mL
ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI)	ASIAN GINSENG	1 [hp_X]  in 1 mL
NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D)	NUPHAR LUTEUM ROOT	2 [hp_X]  in 1 mL
BOS TAURUS TESTICLE (UNII: PR4RXL6G2H) (BOS TAURUS TESTICLE - UNII:PR4RXL6G2H)	BOS TAURUS TESTICLE	6 [hp_X]  in 1 mL
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) (POPULUS TREMULOIDES BARK - UNII:5543O0CEID)	POPULUS TREMULOIDES BARK	1 [hp_X]  in 1 mL
POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0)	POPULUS TREMULOIDES LEAF	1 [hp_X]  in 1 mL
TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)	TESTOSTERONE	30 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786)	THUJA OCCIDENTALIS LEAF	200 [hp_C]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43853-0005-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/16/2013

Labeler - ProBLEN (838787161)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43853-0005) , api manufacture(43853-0005) , label(43853-0005) , pack(43853-0005)