Gynobalance Liquid
FDA Label NDC 43857-0033

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bioactive Nutritional, Inc. for the product Gynobalance (NDC 43857-0033). 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:, indications:, warnings:, directions:, inactive ingredients:, keep out of reach of children:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

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

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.

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

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.

Directions:

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

Inactive Ingredients:

Citric Acid, Demineralized Water, Glycerin, Sodium Benzoate

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.

Questions:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

Package Label Display:

BIOActive Nutritional

GYNOBALANCE

HOMEOPATHIC

1 FL OZ (30 ml)

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