Gynestat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-08-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:27:42

Label at a glance#

ProductGynestat
Active ingredientBLACK COHOSH, EUCALYPTUS GLOBULUS LEAF, SILVER NITRATE, SODIUM TETRACHLOROAURATE, SODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, POTASSIUM DICHROMATE, WOOD CREOSOTE, LILIUM LANCIFOLIUM WHOLE FLOWERING, MERCURIUS SOLUBILIS, PULSATILLA PRATENSIS WHOLE, SEPIA OFFICINALIS JUICE, DELPHINIUM STAPHISAGRIA SEED, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Indications and uses

May temporarily relieve • menstrual pain • vaginal irritation** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. • Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop) Argentum Nitricum 12X 8.32%, Aurum Muriaticum Natronatum 12X 8.32%, Borax 12X 8.32%, Calcarea Carbonica 12X 8.32%, Kali Bichromicum 12X 8.32%, Kreosotum 12X 8.32%, Lilium Tigrinum 12X 8.32%, Mercurius Solubilis 12X 8.32%, Pulsatilla 12X 8.32%, Sepia 12X 8.32%, Staphysagria 12X 8.32%, Thuja Occidentalis 12X 8.32%, Cimicifuga Racemosa 3X 0.10%, Eucalyptus Globulus 3X 0.10%

PURPOSE:

OTC - PURPOSE SECTION

Argentum Nitricum – menstrual Headache,** Aurum Muriaticum Natronatum – pelvic congestion,** Borax – loss of libido,** Calcarea Carbonica – menstrual cramps,** Kali Bichromicum – nausea during menses,** Kreosotum – premenstrual swelling,** Lilium Tigrinum – desire to support pelvis,** Mercurius Solubilis – vaginal odor,** Pulsatilla – vaginal discharge,** Sepia – dragging sensation in pelvis,** Staphysagria – painful intercourse,** Thuja Occidentalis – vaginal itching,** Cimicifuga Racemosa – pelvic pain,** Eucalyptus Globulus – bladder weakness**

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

USES:

INDICATIONS & USAGE SECTION

May temporarily relieve

• menstrual pain • vaginal irritation**

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

WARNINGS:

WARNINGS SECTION

Stop use and ask a doctor if symptoms persist for more than 7 days.

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional.

• Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579

800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GYNESTAT

1 fL. oz. (30 ml)

GYNESTATGYNESTAT

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0716-1Gynestat30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0716GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, AURUM MURIATICUM NATRONATUM, BORAX, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, LILIUM TIGRINUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1Current NDC, 1 package rows20240805_3af1d2f1-b3f3-4135-9148-726d08bbd5d4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-071644911-0716-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GynestatCIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, AURUM MURIATICUM NATRONATUM, BORAX, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, LILIUM TIGRINUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISEnergique, Inc.3af1d2f1-b3f3-4135-9148-726d08bbd5d42024-08-02WarningsExact identifier
ndc (package): 44911-0716-1
ndc (product): 44911-0716
ndc11 (package): 44911071601
spl id: f4878551-dc72-456e-b285-028b5bfdafcb
spl set id: 3af1d2f1-b3f3-4135-9148-726d08bbd5d4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.