ANDROBALANCE- androstenedione, dehydroepiandrosterone, 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

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

INDICATIONS

For temporary relief of symptoms due to male andropause such as: lethargy, muscle weakness and aches, and decrease in libido.

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

One spray three times per day. Hold in mouth for two minutes.

INACTIVE INGREDIENTS

Glycerin, Sodium Benzoate, Citric Acid, Demineralized Water

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS AND USAGE

For temporary relief of symptoms due to male andropause such as: lethargy, muscle weakness and aches, and decrease in libido.

QUESTIONS

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

BioActive Homeopathic

ANDROBALANCE

1 FL OZ (30 ml)

Androbalance

ANDROBALANCE
androstenedione, dehydroepiandrosterone, pregnenolone, progesterone, testosterone liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43857-0102
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ANDROSTENEDIONE (UNII: 409J2J96VR) (ANDROSTENEDIONE - UNII:409J2J96VR)	ANDROSTENEDIONE	6 [hp_X] in 1 mL
7-OXO-PRASTERONE (UNII: 2334LJD2E9) (7-OXO-PRASTERONE - UNII:2334LJD2E9)	7-OXO-PRASTERONE	6 [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
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0102-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/26/2012	04/22/2018

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0102) , api manufacture(43857-0102) , label(43857-0102) , pack(43857-0102)

Revised: 6/2015

Document Id: aae7a690-7b3d-4dc8-8c6d-319ff1fd6663

Set id: 4c15779a-0107-464b-9fae-231bb54ac363

Version: 2

Effective Time: 20150630

BioActive Nutritional, Inc.