Gynobalance (Dehydroepiandrosterone, Estradiol, Pregnenolone, Progesterone, Testosterone) Liquid [Bioactive Nutritional, Inc.] -

GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]
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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

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

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

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

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