Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 3af1d2f1-b3f3-4135-9148-726d08bbd5d4
Route
ORAL
Published
Effective Date 2024-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Black Cohosh (3 [hp_X]) Eucalyptus Globulus Leaf (12 [hp_X]) Silver Cation Tetrachloroaurate Ion Borate Ion Oyster Shell Calcium Carbonate, Crude Dichromate Ion Wood Creosote Lilium Lancifolium Whole Flowering Mercurius Solubilis Pulsatilla Pratensis Whole Sepia Officinalis Juice Delphinium Staphisagria Seed Thuja Occidentalis Leafy Twig
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-08-02

Description

(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

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.


Medication Information

Purpose

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.

Description

(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%

Uses:

May temporarily relieve

• menstrual pain • vaginal irritation**

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

Purpose:

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.

Warnings:

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.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579

800-869-8078

Directions:

• 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.

Active Ingredients:

(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%

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GYNESTAT

1 fL. oz. (30 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Uses: (USES:)

May temporarily relieve

• menstrual pain • vaginal irritation**

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

Purpose: (PURPOSE:)

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.

Warnings: (WARNINGS:)

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.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579

800-869-8078

Directions: (DIRECTIONS:)

• 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.

Active Ingredients: (ACTIVE INGREDIENTS:)

(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%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GYNESTAT

1 fL. oz. (30 ml)

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.


Advanced Ingredient Data


Raw Label Data

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