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Drug Facts:

SPL v5

SPL

SPL Set ID 61fa6e6e-42f5-4992-87b5-0770218abc8c

Route

ORAL

Published

Effective Date 2021-07-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Prasterone (6 [hp_X]) Estradiol (8 [hp_X]) Pregnenolone Progesterone Testosterone

Inactive Ingredients

Anhydrous Citric Acid Glycerin Sodium Benzoate Water Alcohol

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2013-01-18

Description

DHEA (Dehydroepiandrosterone) 6X, Estradiol 8X, Pregnenolone 8X, Progesterone 8X, Testosterone 8X.

Medication Information

Description

DHEA (Dehydroepiandrosterone) 6X, Estradiol 8X, Pregnenolone 8X, Progesterone 8X, Testosterone 8X.

Warnings:

If pregnant or breast-feeding, ask a health care 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 cool, dry place.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions:

Three sprays per day. Hold in mouth for two minutes.

Indications:

For temporary relief of symptoms due to menopausal hot flashes, loss of libido; may enhance calcium metabolism, feelings of well-being and mental clarity.

Active Ingredients:

DHEA (Dehydroepiandrosterone) 6X, Estradiol 8X, Pregnenolone 8X, Progesterone 8X, Testosterone 8X.

Inactive Ingredients:

Citric Acid, Demineralized Water, Ethanol 0.07%, Glycerin, Sodium Benzoate.

Package Label Display:

BIOActive Nutritional

GYNOBALANCE

HOMEOPATHIC

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.

Structured Label Content

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health care 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 cool, dry place.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

Three sprays per day. Hold in mouth for two minutes.

Indications: (INDICATIONS:)

For temporary relief of symptoms due to menopausal hot flashes, loss of libido; may enhance calcium metabolism, feelings of well-being and mental clarity.

Active Ingredients: (ACTIVE INGREDIENTS:)

DHEA (Dehydroepiandrosterone) 6X, Estradiol 8X, Pregnenolone 8X, Progesterone 8X, Testosterone 8X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Citric Acid, Demineralized Water, Ethanol 0.07%, Glycerin, Sodium Benzoate.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

GYNOBALANCE

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children: (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

[{"name": "PRASTERONE", "unii": "459AG36T1B", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ESTRADIOL", "unii": "4TI98Z838E", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PREGNENOLONE", "unii": "73R90F7MQ8", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PROGESTERONE", "unii": "4G7DS2Q64Y", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "TESTOSTERONE", "unii": "3XMK78S47O", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"WARNINGS:": "If pregnant or breast-feeding, ask a health care 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 cool, dry place.", "QUESTIONS:": "Distributed by: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935 bioactivenutritional.com", "DIRECTIONS:": "Three sprays per day. Hold in mouth for two minutes.", "INDICATIONS:": "For temporary relief of symptoms due to menopausal hot flashes, loss of libido; may enhance calcium metabolism, feelings of well-being and mental clarity.", "ACTIVE INGREDIENTS:": "DHEA (Dehydroepiandrosterone) 6X, Estradiol 8X, Pregnenolone 8X, Progesterone 8X, Testosterone 8X.", "INACTIVE INGREDIENTS:": "Citric Acid, Demineralized Water, Ethanol 0.07%, Glycerin, Sodium Benzoate.", "PACKAGE LABEL DISPLAY:": "BIO Active Nutritional GYNOBALANCE HOMEOPATHIC 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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:13.859096 · Updated: 2026-03-14T23:16:23.531871