Label: PROBLEN ESTROGEN AND PROGESTERONE- agnus castus, angelica sinensis, radix, apis mellifica, arnica montana, cimicifuga racemosa, estradiol, estriol, folliculinum, galium aparine, glycyrrhiza glabra, korean ginseng, spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated February 6, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Agnus castus 3X, Angelica sinensis, radix 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.

  • PURPOSE

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

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    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.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Organic alcohol 30% v/v, Purified water.

  • 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.

  • INDICATIONS & USAGE

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

  • QUESTIONS

    Distributed by

    ProBLEN

    2850 Shoreline Trail

    Rockwall, TX 75032

    www.problen.com


  • PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC ORGANOTHERAPY

    Estrogen and Progesterone

    1.O FL OZ (30ML)

    proBLEN

    Estrogen and Progesterone

  • INGREDIENTS AND APPEARANCE
    PROBLEN ESTROGEN AND PROGESTERONE 
    agnus castus, angelica sinensis, radix, apis mellifica, arnica montana, cimicifuga racemosa, estradiol, estriol, folliculinum, galium aparine, glycyrrhiza glabra, korean ginseng, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50845-0169
    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:50845-0169-31 in 1 CARTON
    1NDC:50845-0169-21 in 1 CARTON
    1NDC:50845-0169-130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/31/2012
    Labeler - Liddell Laboratories, Inc. (832264241)
    Establishment
    NameAddressID/FEIBusiness Operations
    Liddell Laboratories, Inc.832264241manufacture
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