Label: BALANCE- bryonia, ignatia, nux vom, phos, sepia 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 February 21, 2013

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  • Active Ingredients


    Each dose contains:

    Bryonia 10C, 20C, 30C HPUS

    Ignatia 10C, 20C, 30C HPUS

    Nux Vom 10C, 20C, 30C HPUS

    Phos 10C, 20C, 30C HPUS

    Sepia 10C, 20C, 30C HPUS

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


  • Purpose


    Bryonia 10C, 20C, 30C HPUS.....................Minor headache, Sleeplessness

    Ignatia 10C, 20C, 30C HPUS......................Sexual frigidity, Changeable mood

    Nux Vom 10C, 20C, 30C HPUS..................Faintness, Sleeplessness

    Phos 10C, 20C, 30C HPUS........................Aversion to coitus, Great indifference

    Sepia 10C, 20C, 30C HPUS........................Hot flashes, Weakness


  • Uses

    Temporarily relieves symptoms of menstrual irregularities such as: membrane dryness, hot flashes, sleeplessness, weakness or faintness, perspiration, sexual frigidity and minor headache pain as per Homeopathic Materia Medica.

  • Warnings

    If pregnant or breast feeding, ask a health professional before use. 

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

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

  • Directions

    Shake well before using. Spay 3 to 6 sprays under the tongue 3 times a day or as needed. Adults and children under 18 years of age consult a physician.

  • Inactive Ingredients

    Barbasco Extract, Black Cohosh Extract, Damiana, Eleuthero, Malic Acid, Muira Puama,

    Natural Flavors, Potassium Sorbate, Sodium Benzoate, Stevia Leaf Extract, Tribulus, Water.

  • STORAGE AND HANDLING

    Safety-sealed for your protection. Do not use if seal is missing or broken.


  • QUESTIONS

    Questions? Comments?

    877-272-6611

    Distributed by

    BDMP LLC

    1080 Bichara Boulevard

    Lady Lake, Fl. 32159

    Made in the USA

  • DESCRIPTION

    Temporarily relieves symptoms of menstrual irregularities such as hot flashes, sleeplessness, weakness or

    faintness and low libido.


    Homeopathic Spray

  • Principal Display Panel

    MM1

    NDC 54616-001-00

                               BALANCE

                               BY FEMBALANCE

    2 fl oz (60 mL)    Homeopathic Spray

    Temporarily relieves symptoms of menstrual irregularities such as

    hot flashes sleeplessness, weakness or faintness and low libido.


  • INGREDIENTS AND APPEARANCE
    BALANCE  
    bryonia, ignatia, nux vom, phos, sepia spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54616-001
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_C]  in 60 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED30 [hp_C]  in 60 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]  in 60 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_C]  in 60 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_C]  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    BARBASCO (UNII: 5ZAQ44W04C)  
    BLACK COHOSH (UNII: K73E24S6X9)  
    TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ)  
    ELEUTHERO (UNII: ZQH6VH092Z)  
    MALIC ACID (UNII: 817L1N4CKP)  
    DULACIA INOPIFLORA WOOD (UNII: K04M7D9VEC)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    TRIBULUS TERRESTRIS (UNII: 4X4HLN92OT)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54616-001-601 in 1 CARTON
    160 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/21/2013
    Labeler - BDMP, LLC (078676990)
    Establishment
    NameAddressID/FEIBusiness Operations
    Adjunct Therapeutics Manufacturing, LLC043042937manufacture(54616-001)
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