GYNOBALANCE- dehydroepiandrosterone, estradiol, pregnenolone, progesterone, testosterone liquid

Gynobalance by

Drug Labeling and Warnings

Gynobalance by is a Homeopathic medication manufactured, distributed, or labeled by BioActive Nutritional, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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.

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)

INGREDIENTS AND APPEARANCE

GYNOBALANCE 
dehydroepiandrosterone, estradiol, pregnenolone, progesterone, testosterone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0033
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B)	PRASTERONE	6 [hp_X]  in 1 mL
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	8 [hp_X]  in 1 mL
PREGNENOLONE (UNII: 73R90F7MQ8) (PREGNENOLONE - UNII:73R90F7MQ8)	PREGNENOLONE	8 [hp_X]  in 1 mL
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)	PROGESTERONE	8 [hp_X]  in 1 mL
TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)	TESTOSTERONE	8 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0033-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/18/2013

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0033) , api manufacture(43857-0033) , label(43857-0033) , pack(43857-0033)