ANDROBALANCE - androstenedione, dehydroepiandrosterone, pregenolone, progesterone, testosterone spray 
Apotheca Company

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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Androbalance

Active Ingredients:  Androstenedione 6X, Dehydroepiandrosterone 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 a 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.  Consult a physician for use in children under 12 years of age.

Indications:

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

Inactive Ingredients:  Citric Acid, Demineralized Water, Glycerin, Sodium Benzonate, 25% Ethanol.

Distributed By:    BioActive Nutritional

                              Melbourne, FL 32935

For Nutritional Information Write To:   BioActive Nutritional

                                                                1803 N. Wickham Rd.

                                                                Melbourne, FL 32935


BioActive Homeopathic

ANDROBALANCE

1 FL OZ (30 ML)

Androbalance

ANDROBALANCE 
androstenedione, dehydroepiandrosterone, pregenolone, progesterone, testosterone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANDROSTENEDIONE (UNII: 409J2J96VR) (ANDROSTENEDIONE - UNII:409J2J96VR) ANDROSTENEDIONE6 [hp_X]  in 1 mL
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57520-0023-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/01/201003/13/2017
Labeler - Apotheca Company (844330915)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(57520-0023) , api manufacture(57520-0023) , label(57520-0023) , pack(57520-0023)

Revised: 5/2015
Document Id: f3b4c490-53f9-4c99-a1f6-b52b1bf1bba2
Set id: f5b62b9d-5750-47f6-b497-4da06000506b
Version: 3
Effective Time: 20150528
 
Apotheca Company