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 3X, 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 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 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
2850 Shoreline Trail,
Rockwall, TX 75032
www.problen.com

PACKAGE LABEL DISPLAY:

HOMEOPATHIC

ORGANOTHERAPY

Estro

gen

&

Progesterone

1.0 FL. OZ. (30ML)

proBLEN

Estrogen & Progesterone     lbl

Estrogen & 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:43853-0017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE3 [hp_X]  in 1 mL
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG) ANGELICA SINENSIS ROOT3 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH3 [hp_X]  in 1 mL
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL9 [hp_C]  in 1 mL
ESTRIOL (UNII: FB33469R8E) (ESTRIOL - UNII:FB33469R8E) ESTRIOL9 [hp_C]  in 1 mL
ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A) ESTRONE9 [hp_C]  in 1 mL
GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE3 [hp_X]  in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA3 [hp_X]  in 1 mL
ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG3 [hp_X]  in 1 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY30 [hp_C]  in 1 mL
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE6 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_C]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]  in 1 mL
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43853-0017-21 in 1 CARTON01/12/2017
1NDC:43853-0017-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/12/2017
Labeler - ProBLEN (838787161)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43853-0017) , api manufacture(43853-0017) , label(43853-0017) , pack(43853-0017)

Revised: 1/2017
Document Id: 31103d8c-5ee4-483e-bd45-aac9eda84b68
Set id: 71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf
Version: 1
Effective Time: 20170112
 
ProBLEN