Label: ANDROBALANCE (dhea- dehydroepiandrosterone pregnenolone, progesterone, testosterone spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated April 13, 2017

If you are a consumer or patient please visit this version.

  • 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 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.

  • 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 and aches, and decrease in libido.

  • INACTIVE INGREDIENTS: 

    Citric Acid, Demineralized water, 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

  • INGREDIENTS AND APPEARANCE
    ANDROBALANCE 
    dhea (dehydroepiandrosterone) pregnenolone, progesterone, testosterone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0284
    Route of AdministrationORAL
    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)  
    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)