Label: HORMONE BALANCE- salsolinol hydrochloride, dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone-3b-acetate, folliculinum, oophorinum (suis), cholesterinum, progesterone, testosterone, cortisone aceticum, aldosterone, androsterone, follicle stimulating hormone liquid

  • 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 November 30, 2018

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

  • ACTIVE INGREDIENTS:

    Salsolinol (Hydrochloride) 6X, 12X, 30X, 200X, DHEA (Dehydroepiandrosterone) 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, 7-Oxo-Dehydroepiandrosterone 3-Acetate 8X, 12X, 30X, 60X, 200X, 12C, 30C, 60C, 200C, Folliculinum 8X, 12X, 30X, 60X, 200X, 12C, 30C, 60C, 200C, Oophorinum (Suis) 8X, 12X, 30X, 60X, 200X, 12C, 30C, 60C, 200C, Cholesterinum 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C,Progesterone 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Testosterone 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Cortisone Aceticum 12X, 30X, 200X, 12C, 30C, 60C, 200C, Aldosterone 12C, 30C, 60C, 200C, Androsterone 12C, 30C, 60C, 200C, Follicle Stimulating Hormone 12C, 30C, 60C, 200C.

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  • HOMEOPATHIC INDICATIONS:

    Temporary relief of symptoms related to hormone imbalances or insufficiencies in men and women, including low energy, inability to handle stress, trouble focusing, changes in mood, infertility, irregular menstrual cycles (females) and lack of libido.**

    **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

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  • WARNINGS:

    Keep out of reach of children. In case of overdose, get medical help or contact or a Poison Control Center right away.

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

    Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

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  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact or a Poison Control Center right away.

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  • DIRECTIONS:

    10 drops under the tongue, 3 to 6 times per day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

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  • HOMEOPATHIC INDICATIONS:

    Temporary relief of symptoms related to hormone imbalances or insufficiencies in men and women, including low energy, inability to handle stress, trouble focusing, changes in mood, infertility, irregular menstrual cycles (females) and lack of libido.**

    **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

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  • INACTIVE INGREDIENTS:

    demineralized water, 25% ethanol.

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  • QUESTIONS:

    Distributed by Dr. Donna Restivo DC, Wellness Consultant
    822 South Lake Blvd, Mahopac, New York 10541
    www.mahopacmassage.com • (845) 628-6286

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  • PACKAGE LABEL DISPLAY:

    DR. DONNA RESTIVO DC
    WELLNESS CONSULTANT
    NDC 62185-0041-1
    HOMEOPATHIC
    Hormone Balance
    1 FL OZ (30 ml)

    Hormone Balance

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  • INGREDIENTS AND APPEARANCE
    HORMONE BALANCE 
    salsolinol hydrochloride, dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone-3b-acetate, folliculinum, oophorinum (suis), cholesterinum, progesterone, testosterone, cortisone aceticum, aldosterone, androsterone, follicle stimulating hormone liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62185-0041
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALSOLINOL HYDROCHLORIDE, (+/-)- (UNII: 1C0F27WEAL) (SALSOLINOL HYDROCHLORIDE, (+/-)- - UNII:1C0F27WEAL) SALSOLINOL HYDROCHLORIDE, (+/-)- 6 [hp_X]  in 1 mL
    PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B) PRASTERONE 6 [hp_X]  in 1 mL
    7-OXODEHYDROEPIANDROSTERONE 3-ACETATE (UNII: 84RQ0XOM11) (7-OXODEHYDROEPIANDROSTERONE 3-ACETATE - UNII:84RQ0XOM11) 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE 8 [hp_X]  in 1 mL
    ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A) ESTRONE 8 [hp_X]  in 1 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY 8 [hp_X]  in 1 mL
    CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J) CHOLESTEROL 8 [hp_X]  in 1 mL
    PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE 8 [hp_X]  in 1 mL
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE 8 [hp_X]  in 1 mL
    CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE 12 [hp_X]  in 1 mL
    ALDOSTERONE (UNII: 4964P6T9RB) (ALDOSTERONE - UNII:4964P6T9RB) ALDOSTERONE 12 [hp_C]  in 1 mL
    ANDROSTERONE (UNII: C24W7J5D5R) (ANDROSTERONE - UNII:C24W7J5D5R) ANDROSTERONE 12 [hp_C]  in 1 mL
    FOLLITROPIN (UNII: 076WHW89TW) (FOLLITROPIN - UNII:076WHW89TW) FOLLITROPIN 12 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62185-0041-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 11/30/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 11/30/2018
    Labeler - Dr. Donna Restivo DC (790796940)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(62185-0041) , api manufacture(62185-0041) , label(62185-0041) , pack(62185-0041)
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