Label: HORMONE BALANCE (salsolinol hydrochloride, cholesterinum, dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone 3-acetate, folliculinum, oophorinum- suis, 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 December 19, 2018

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

  • ACTIVE INGREDIENTS:

    Salsolinol (Hydrochloride) 6X, 12X, 30X, 200X, Cholesterinum 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, 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, 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.

  • HOMEOPATHIC INDICATIONS:

    For temporary relief of symptoms related to menstrual and cyclic related conditions including emotional swings, headache, irritability, cravings and fluid retention in both menopause and andropause.**

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

  • 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.

  • 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.

  • 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.

  • HOMEOPATHIC INDICATIONS:

    For temporary relief of symptoms related to menstrual and cyclic related conditions including emotional swings, headache, irritability, cravings and fluid retention in both menopause and andropause.**

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

  • INACTIVE INGREDIENTS:

    demineralized water, 25% ethanol.

  • QUESTIONS:

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

  • PACKAGE LABEL DISPLAY:

    DR. DONNA RESTIVO DC
    WELLNESS CONSULTANT
    NDC 62185-0018-1
    HOMEOPATHIC
    HORMONE BALANCE
    1 FL OZ (30 ml)

    Hormone Balance

  • INGREDIENTS AND APPEARANCE
    HORMONE BALANCE 
    salsolinol hydrochloride, cholesterinum, dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone 3-acetate, folliculinum, oophorinum (suis), progesterone, testosterone, cortisone aceticum, aldosterone, androsterone, follicle stimulating hormone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62185-0018
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALSOLINOL HYDROCHLORIDE, (+/-)- (UNII: 1C0F27WEAL) (SALSOLINOL HYDROCHLORIDE, (+/-)- - UNII:1C0F27WEAL) SALSOLINOL HYDROCHLORIDE, (+/-)-6 [hp_X]  in 1 mL
    CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J) CHOLESTEROL6 [hp_X]  in 1 mL
    PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B) PRASTERONE6 [hp_X]  in 1 mL
    7-OXODEHYDROEPIANDROSTERONE 3-ACETATE (UNII: 84RQ0XOM11) (7-OXODEHYDROEPIANDROSTERONE 3-ACETATE - UNII:84RQ0XOM11) 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE8 [hp_X]  in 1 mL
    ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A) ESTRONE8 [hp_X]  in 1 mL
    SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY8 [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
    CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE12 [hp_X]  in 1 mL
    ALDOSTERONE (UNII: 4964P6T9RB) (ALDOSTERONE - UNII:4964P6T9RB) ALDOSTERONE12 [hp_C]  in 1 mL
    ANDROSTERONE (UNII: C24W7J5D5R) (ANDROSTERONE - UNII:C24W7J5D5R) ANDROSTERONE12 [hp_C]  in 1 mL
    FOLLITROPIN (UNII: 076WHW89TW) (FOLLITROPIN - UNII:076WHW89TW) FOLLITROPIN12 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62185-0018-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/13/201606/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/13/201606/27/2023
    Labeler - Dr. Donna Restivo DC (790796940)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(62185-0018) , api manufacture(62185-0018) , label(62185-0018) , pack(62185-0018)