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 
Dr. Donna Restivo DC

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.

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Drug Facts:

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

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)

Revised: 12/2018
 
Dr. Donna Restivo DC