Label: GYNESTAT (cimicifuga racemosa, eucalyptus globulus, argentum nitricum, calcarea carbonica, kali bichromicum, kreosotum, mercurius solubilis, pulsatilla- pratensis, sepia, staphysagria, thuja occidentalis liquid

  • 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 May 25, 2021

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  • ACTIVE INGREDIENTS:

    (in each drop): 11.09% of Argentum Nitricum 12X, Calcarea Carbonica 12X, Kali Bichromicum 12X, Kreosotum 12X, Mercurius Solubilis 12X, Pulsatilla (Pratensis) 12X, Sepia 12X, Staphysagria 12X, Thuja Occidentalis 12X; 0.10% of Cimicifuga Racemosa 3X, Eucalyptus Globulus 3X.

  • INDICATIONS:

    May temporarily relieve menstrual pain and vaginal irritation.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health 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 a 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 and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    May temporarily relieve menstrual pain and vaginal irritation.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Demineralized water, 20% Ethanol.

  • QUESTIONS:

    Dist. by Energique, Inc.

    201 Apple Blvd

    Woodbine, IA 51579 800-869-8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE

    SINCE 1987

    HOMEOPATHIC REMEDY

    GYNESTAT

    1 fL. oz. (30 ml)

    Gynestat

  • INGREDIENTS AND APPEARANCE
    GYNESTAT 
    cimicifuga racemosa, eucalyptus globulus, argentum nitricum, calcarea carbonica, kali bichromicum, kreosotum, mercurius solubilis, pulsatilla (pratensis), sepia, staphysagria, thuja occidentalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0279
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH3 [hp_X]  in 1 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF3 [hp_X]  in 1 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE12 [hp_X]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE12 [hp_X]  in 1 mL
    WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE12 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 1 mL
    PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS12 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED12 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0279-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/23/2015
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0279) , api manufacture(44911-0279) , label(44911-0279) , pack(44911-0279)
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