GYNOBALANCE- dehydroepiandrosterone, estradiol, pregnenolone, progesterone, testosterone liquid 
BioActive Nutritional, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

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.

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.

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.

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.

INACTIVE INGREDIENTS:

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

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)

Gynobalance

GYNOBALANCE 
dehydroepiandrosterone, estradiol, pregnenolone, progesterone, testosterone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0033
Route of AdministrationORALDEA ScheduleCIII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B) PRASTERONE6 [hp_X]  in 1 mL
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL8 [hp_X]  in 1 mL
PREGNENOLONE (UNII: 73R90F7MQ8) (PREGNENOLONE - UNII:73R90F7MQ8) PREGNENOLONE8 [hp_X]  in 1 mL
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE8 [hp_X]  in 1 mL
TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE8 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0033-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/18/2013
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0033) , api manufacture(43857-0033) , label(43857-0033) , pack(43857-0033)

Revised: 8/2023
Document Id: 24deb803-ab80-49ec-81e5-4ef5ce24fcf5
Set id: 61fa6e6e-42f5-4992-87b5-0770218abc8c
Version: 5
Effective Time: 20230810
 
BioActive Nutritional, Inc.