Label: BALANCE  - bryonia alba root, strychnos ignatii seed, strychnos nux-vomica seed, phosphorus and sepia officinalis juice spray 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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

  • 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.


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  • 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


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  • 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.

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  • Warnings

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • WARNINGS

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

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  • 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.

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  • Inactive Ingredients

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

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

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  • STORAGE AND HANDLING

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


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  • QUESTIONS

    Questions? Comments?

    877-272-6611

    Distributed by

    BDMP LLC

    1080 Bichara Boulevard

    Lady Lake, Fl. 32159

    Made in the USA

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  • DESCRIPTION

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

    faintness and low libido.


    Homeopathic Spray

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  • 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.


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  • INGREDIENTS AND APPEARANCE
    BALANCE  
    bryonia, ignatia, nux vom, phos, sepia spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54616-001
    Route of Administration SUBLINGUAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 30 [hp_C]  in 60 mL
    STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED 30 [hp_C]  in 60 mL
    STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 30 [hp_C]  in 60 mL
    PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 30 [hp_C]  in 60 mL
    SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 30 [hp_C]  in 60 mL
    Inactive Ingredients
    Ingredient Name Strength
    BARBASCO  
    BLACK COHOSH  
    TURNERA DIFFUSA LEAFY TWIG  
    ELEUTHERO  
    MALIC ACID  
    DULACIA INOPIFLORA WOOD  
    POTASSIUM SORBATE  
    SODIUM BENZOATE  
    STEVIA REBAUDIUNA LEAF  
    TRIBULUS TERRESTRIS  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54616-001-60 1 in 1 CARTON
    1 60 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 02/21/2013
    Labeler - BDMP, LLC (078676990)
    Establishment
    Name Address ID/FEI Business Operations
    Adjunct Therapeutics Manufacturing, LLC 043042937 manufacture(54616-001)
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