Gynobalance
DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE · BioActive Nutritional, Inc. · ORAL
Open FDA's page for this record- Set ID
- 61fa6e6e-42f5-4992-87b5-0770218abc8c
- ID
- 0bf415b8-a443-4bbc-87c3-84ebe76d51bc
- Effective time
- 20260824
- Version
- 6
- SPL product data elements
Gynobalance Dehydroepiandrosterone, Estradiol, Pregnenolone, Progesterone, Testosterone PRASTERONE PRASTERONE ESTRADIOL ESTRADIOL PREGNENOLONE PREGNENOLONE PROGESTERONE PROGESTERONE TESTOSTERONE TESTOSTERONE ANHYDROUS CITRIC ACID GLYCERIN SODIUM BENZOATE WATER ALCOHOL
- Active ingredient
- ACTIVE INGREDIENTS: DHEA (Dehydroepiandrosterone) 6X, Estradiol 8X, Pregnenolone 8X, Progesterone 8X, Testosterone 8X.
- Purpose
PURPOSE: DHEA (Dehydroepiandrosterone) - fatigue,** Estradiol – low sex drive,** Pregnenolone – hormone balancer,** Progesterone - irritability,** Testosterone – decreased sex drive.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
- Indications and usage
USES: For temporary relief of symptoms due to menopausal hot flashes, loss of libido; for enhancing feelings of wellbeing, enhance calcium metabolism, and improving mental clarity.** **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.
- 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.
- Dosage and administration
DIRECTIONS: • 1 spray orally, 3 times a day or as directed by a health care professional. • Consult a health are professional for use in children under 12 years of age.
- Inactive ingredient
- INACTIVE INGREDIENTS: Citric Acid, Demineralized Water, Ethanol 0.07%, Glycerin, Sodium Benzoate.
- Questions
- QUESTIONS: Distributed by: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935 bioactivenutritional.com 1-800-288-9525
- Package label principal display panel
- PACKAGE LABEL DISPLAY: BIO Active Nutritional GYNOBALANCE HOMEOPATHIC 1 fl. oz. (30 mL) GYNOBALANCE
- Harmonized identifiers (openFDA)
- Brand name
- Gynobalance
- Generic name
- DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE
- Manufacturer name
- BioActive Nutritional, Inc.
- Product NDC
- 43857-0033
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Substance name
- PRASTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE
- SPL ID
- 0bf415b8-a443-4bbc-87c3-84ebe76d51bc
- SPL set ID
- 61fa6e6e-42f5-4992-87b5-0770218abc8c
- Package NDC
- 43857-0033-1
- Is original packager
- true
- Upc
- 0210184340995
- Nui
- M0447348, N0000175825, N0000000100, M0017672, N0000175601, N0000175824, N0000000146, M0001109
- Pharm class cs
- Estradiol Congeners [CS], Progesterone [CS], Androstanes [CS]
- Pharm class epc
- Estrogen [EPC], Progesterone [EPC], Androgen [EPC]
- Pharm class moa
- Estrogen Receptor Agonists [MoA], Androgen Receptor Agonists [MoA]
- UNII
- 459AG36T1B, 4TI98Z838E, 73R90F7MQ8, 4G7DS2Q64Y, 3XMK78S47O