ANDROBALANCE (dhea- dehydroepiandrosterone pregnenolone, progesterone, testosterone spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B), PREGNENOLONE (UNII: 73R90F7MQ8) (PREGNENOLONE - UNII:73R90F7MQ8), PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y), TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)

Available from:

BioActive Nutritional, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

unapproved homeopathic

Summary of Product characteristics

ANDROBALANCE- DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE,
PROGESTERONE, TESTOSTERONE SPRAY
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, Pregnenolone 8X, Progesterone 8X,
Testosterone
8X.
INDICATIONS:
For temporary relief of symptoms due to male andropause such as:
lethargy, muscle
weakness & 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.
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:
One spray three times per day. Hold in mouth for two minutes.
INDICATIONS:
For temporary relief of symptoms due to male andropause such as:
lethargy, muscle
weakness & aches, and decrease in libido.
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
ANDROBALANCE
HOMEOPATHIC
1 FL OZ (30 ML)
ANDROBALANCE
dhea (dehydroepiandrosterone) pregnenolone, progesterone, testosterone
spray
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:43857-0284
ROUTE OF ADMINISTRATION
ORAL
DEA SCHEDULE
CIII
ACTIVE INGREDIENT/ACTIVE MOIETY
BioActive Nutritional, Inc.
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B)
PRASTERONE
6 [hp_X] in 1 mL
PREGNENOLONE (UNII: 73R90F7MQ8) (PREGNENOLONE - UNII:73R90F7MQ8)
PREGNENOLONE
8 [hp_X] in 1 mL
PROGESTERONE