Drug Facts:

Drug Facts:
SPL v5
SPL
SPL Set ID 78ad2598-3e80-4571-81cb-7bd50d770153
Route
ORAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Estrone (6 [hp_X]) Progesterone
Inactive Ingredients
Glycerin Sodium Benzoate Citric Acid Monohydrate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-08-01

Description

Folliculinum 6X, Progesterone 6X.

Purpose

Folliculinum - andropause symptoms,** Progesterone - irritability** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Folliculinum - andropause symptoms,** Progesterone - irritability** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Folliculinum 6X, Progesterone 6X.

Uses:

For temporary relief of moodiness, nervousness, irritability, irregular menses, improving skin texture, restoring sexual function and improving calcium metabolism.**

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

Purpose:

Folliculinum - andropause symptoms,** Progesterone - irritability**

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

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 a cool, dry place.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions:

• Three sprays per day.

Hold in mouth for two minutes.

Active Ingredients:

Folliculinum 6X, Progesterone 6X.

Inactive Ingredients:

Citric Acid, Demineralized Water, Ethanol 0.1%, Glycerin, Sodium Benzoate.

Package Label Display:

BIOActive Nutritional

FEMALE BALANCE

HOMEOPATHIC

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:)

For temporary relief of moodiness, nervousness, irritability, irregular menses, improving skin texture, restoring sexual function and improving calcium metabolism.**

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

Purpose: (PURPOSE:)

Folliculinum - andropause symptoms,** Progesterone - irritability**

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

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 a cool, dry place.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions: (DIRECTIONS:)

• Three sprays per day.

Hold in mouth for two minutes.

Active Ingredients: (ACTIVE INGREDIENTS:)

Folliculinum 6X, Progesterone 6X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Citric Acid, Demineralized Water, Ethanol 0.1%, Glycerin, Sodium Benzoate.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

FEMALE BALANCE

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.


Advanced Ingredient Data


Raw Label Data

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