Hormone Balance
Drug Facts:
421707d6-31c1-4d57-b017-796fc872efe4
HUMAN OTC DRUG LABEL
May 23, 2025
Dr. Donna Restivo DC
DUNS: 790796940
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaldehyde, Dopamine Hydrochloride, DHEA (Dehydroepiandrosterone), 7-Oxo-Dehydroepiandrosterone-3B-Acetate, Folliculinum, Oophorinum (Suis), Cholesterinum, Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL DISPLAY:
DR. DONNA RESTIVO DC
WELLNESS CONSULTANT
NDC 62185-0041-1
HOMEOPATHIC
Hormone Balance
1 FL OZ (30 ml)
INDICATIONS & USAGE SECTION
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.
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS:
Acetaldehyde 6X, 12X, 30X, 200X, Dopamine 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.
OTC - PURPOSE SECTION
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.
WARNINGS SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS:
demineralized water, 25% ethanol.
OTC - QUESTIONS SECTION
QUESTIONS:
Distributed by Dr. Donna Restivo DC, Wellness Consultant
822 South Lake Blvd, Mahopac, New York 10541
www.mahopacmassage.com • (845) 628-6286