The following Structured Product Label (SPL) was submitted to the FDA by Energique, Inc. for the product Gynestat (NDC 44911-0716). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, purpose:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(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%
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.
May temporarily relieve
• menstrual pain • vaginal irritation**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
• 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.
Demineralized water, 20% Ethanol.
Dist. by Energique, Inc.
201 Apple Blvd
Woodbine, IA 51579
800-869-8078
ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
GYNESTAT
1 fL. oz. (30 ml)
* Please review the disclaimer below.
