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FDA Approval

Hormone Balance

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Dr. Donna Restivo DC
DUNS: 790796940
Effective Date
May 23, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Dopamine(6 [hp_X] in 1 mL)
7-oxodehydroepiandrosterone 3-acetate(6 [hp_X] in 1 mL)
Estrone(8 [hp_X] in 1 mL)
Cholesterol(8 [hp_X] in 1 mL)
Progesterone(8 [hp_X] in 1 mL)
Testosterone(8 [hp_X] in 1 mL)
Cortisone acetate(12 [hp_X] in 1 mL)
Aldosterone(12 [hp_C] in 1 mL)
androsterone(12 [hp_C] in 1 mL)
Follitropin(12 [hp_C] in 1 mL)
[2-(Methyleneamine)-4-(4-Hydroxy-Benzylidine)-5-Oxo-4,5-Dihydro-Imidazol-1-Yl]-Acetaldehyde(6 [hp_X] in 1 mL)
TVI Ovary 1(8 [hp_X] in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Apotheca Company

844330915

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Apotheca Company

Dr. Donna Restivo DC

Apotheca Company

844330915

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hormone Balance

Product Details

NDC Product Code
62185-0050
Route of Administration
ORAL
Effective Date
May 23, 2025
DopamineActive
Code: 7L3E358N9LClass: ACTIBQuantity: 6 [hp_X] in 1 mL
7-oxodehydroepiandrosterone 3-acetateActive
Code: 84RQ0XOM11Class: ACTIBQuantity: 6 [hp_X] in 1 mL
EstroneActive
Code: 2DI9HA706AClass: ACTIBQuantity: 8 [hp_X] in 1 mL
CholesterolActive
Code: 97C5T2UQ7JClass: ACTIBQuantity: 8 [hp_X] in 1 mL
ProgesteroneActive
Code: 4G7DS2Q64YClass: ACTIBQuantity: 8 [hp_X] in 1 mL
TestosteroneActive
Code: 3XMK78S47OClass: ACTIBQuantity: 8 [hp_X] in 1 mL
Cortisone acetateActive
Code: 883WKN7W8XClass: ACTIBQuantity: 12 [hp_X] in 1 mL
AldosteroneActive
Code: 4964P6T9RBClass: ACTIBQuantity: 12 [hp_C] in 1 mL
androsteroneActive
Code: C24W7J5D5RClass: ACTIBQuantity: 12 [hp_C] in 1 mL
FollitropinActive
Code: 076WHW89TWClass: ACTIBQuantity: 12 [hp_C] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
[2-(Methyleneamine)-4-(4-Hydroxy-Benzylidine)-5-Oxo-4,5-Dihydro-Imidazol-1-Yl]-AcetaldehydeActive
Code: GO1N1ZPR3BClass: ACTIBQuantity: 6 [hp_X] in 1 mL
TVI Ovary 1Active
Code: S7YTV04R8OClass: ACTIBQuantity: 8 [hp_X] in 1 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

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)

Hormone Balance

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.

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.

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 - 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.

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.

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

demineralized water, 25% ethanol.

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