ESTROGEN AND PROGESTERONE- agnus castus, angelica sinensis, apis mellifica, arnica montana, cimicifuga racemosa, estradiol, estriol, folliculinum, galium aparine, glycyrrhiza glabra, korean ginseng, oophorinum (suis), progesterone, sepia, thuja occidentalis, viscum album spray
ProBLEN

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

ACTIVE INGREDIENTS

Agnus Castus 3X, Angelica Sinensis, Apis Mellifica 6X, Arnica Montana 6X, Cimicifuga Racemosa 3X, Estradiol 9C, Estriol 9C, Folliculinum 9C, Galium Aparine 3X, Glycyrrhiza Glabra 3X, Korean Ginseng 3X, Oophorinum Suis 30C, Progesterone 6X, Sepia 30C, Thuja Occidentalis 6X, Viscum Album 3X

INDICATIONS:

Temporarily supports the body to rebalance estrogen output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.

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 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 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 estrogen output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.

INACTIVE INGREDIENTS:

Organic alcohol 30% v/v, Purified Water

QUESTIONS:

Distributed By ProBLEN (888) 326-2121 www.problen.com
2850 Shoreline Trail, Suite 300, Rockwall, TX 75032

PACKAGE LABEL DISPLAY:

Estro

gen

Progesterone

HOMEOPATHIC

ORGANOTHERAPY

1.0 FL. OZ. (30ML) 30% ALCOHOL

proBLEN

Estrogen and Progesterone lbl

Estrogen and Progesterone ctn

ESTROGEN AND PROGESTERONE
agnus castus, angelica sinensis, apis mellifica, arnica montana, cimicifuga racemosa, estradiol, estriol, folliculinum, galium aparine, glycyrrhiza glabra, korean ginseng, oophorinum (suis), progesterone, sepia, thuja occidentalis, viscum album spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43853-0001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A)	CHASTE TREE	3 [hp_X] in 1 mL
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG)	ANGELICA SINENSIS ROOT	3 [hp_X] in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X] in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X] in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	3 [hp_X] in 1 mL
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	9 [hp_C] in 1 mL
ESTRIOL (UNII: FB33469R8E) (ESTRIOL - UNII:FB33469R8E)	ESTRIOL	9 [hp_C] in 1 mL
ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A)	ESTRONE	9 [hp_C] in 1 mL
GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488)	GALIUM APARINE	3 [hp_X] in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H)	GLYCYRRHIZA GLABRA	3 [hp_X] in 1 mL
ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI)	ASIAN GINSENG	3 [hp_X] in 1 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	30 [hp_C] in 1 mL
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)	PROGESTERONE	6 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_C] in 1 mL
THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786)	THUJA OCCIDENTALIS LEAF	6 [hp_X] in 1 mL
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP)	VISCUM ALBUM FRUITING TOP	3 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43853-0001-2	1 in 1 CARTON	11/30/2016	12/21/2020
1	NDC:43853-0001-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/05/2014	12/21/2020

Labeler - ProBLEN (838787161)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43853-0001) , api manufacture(43853-0001) , label(43853-0001) , pack(43853-0001)

Revised: 1/2017

Document Id: 8cc56347-a99b-4a87-8684-96dca3ad9761

Set id: f1ebb163-1679-4564-b6e6-bb2e625ffd29

Version: 3

Effective Time: 20170125

ProBLEN