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

ANDROBALANCE 
dhea (dehydroepiandrosterone) pregnenolone, progesterone, testosterone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0284
Route of AdministrationORALDEA ScheduleCIII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B) PRASTERONE6 [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
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0284-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/13/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/24/2014
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0284) , api manufacture(43857-0284) , label(43857-0284) , pack(43857-0284)

Revised: 6/2023
Document Id: 7d2d1ee4-5a71-4eb5-a989-9577cd116ce0
Set id: e231695a-165a-419e-b594-34f9522503ac
Version: 4
Effective Time: 20230605
 
BioActive Nutritional, Inc.