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NDC 62185-0018-01 Hormone Balance 8; 12; 12; 6; 12; 8; 12; 6; 8; 6; 8; 8 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Hormone Balance 8; 12; 12; 6; 12; 8; 12; 6; 8; 6; 8; 8 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Hormone Balance is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Dr. Donna Restivo DC. The primary component is 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ALDOSTERONE; ANDROSTERONE; CHOLESTEROL; CORTISONE ACETATE; ESTRONE; FOLLITROPIN; PRASTERONE; PROGESTERONE; SALSOLINOL HYDROCHLORIDE, (+/-)-; SUS SCROFA OVARY; TESTOSTERONE.

Product Information

NDC	62185-0018
Product ID	62185-0018_d1b73880-1afe-4c08-a0d9-d2a8b5eac701
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hormone Balance
Proprietary Name Suffix	n/a
Non-Proprietary Name	Salsolinol Hydrochloride, Cholesterinum, DHEA (Dehydroepiandrosterone), 7-Oxo-Dehydroepiandrosterone 3-Acetate, Folliculinum, Oophorinum (Suis), Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	8; 12; 12; 6; 12; 8; 12; 6; 8; 6; 8; 8
Active Ingredient Units	[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ALDOSTERONE; ANDROSTERONE; CHOLESTEROL; CORTISONE ACETATE; ESTRONE; FOLLITROPIN; PRASTERONE; PROGESTERONE; SALSOLINOL HYDROCHLORIDE, (+/-)-; SUS SCROFA OVARY; TESTOSTERONE
Labeler Name	Dr. Donna Restivo DC
Pharmaceutical Class	Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Gonadotropin [EPC], Gonadotropins [CS], Progesterone [CS], Progesterone [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 62185-0018-01 (62185001801)

Pricing Information	N/A
NDC Package Code	62185-0018-1
Billing NDC	62185001801
Package	30 mL in 1 BOTTLE, DROPPER (62185-0018-1)
Marketing Start Date	2016-04-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2e77e321-a263-4918-ae40-7ca883deabbf Details

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:

**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)

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62185-0018
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALSOLINOL HYDROCHLORIDE, (+/-)- (UNII: 1C0F27WEAL) (SALSOLINOL HYDROCHLORIDE, (+/-)- - UNII:1C0F27WEAL)	SALSOLINOL HYDROCHLORIDE, (+/-)-	6 [hp_X] in 1 mL
CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J)	CHOLESTEROL	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
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62185-0018-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/13/2016	06/27/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/13/2016	06/27/2023

Labeler - Dr. Donna Restivo DC (790796940)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(62185-0018) , api manufacture(62185-0018) , label(62185-0018) , pack(62185-0018)

Revised: 12/2018

Document Id: d1b73880-1afe-4c08-a0d9-d2a8b5eac701

Set id: 2e77e321-a263-4918-ae40-7ca883deabbf

Version: 5

Effective Time: 20181219

Search by Drug Name or NDC

NDC 62185-0018-01 Hormone Balance 8; 12; 12; 6; 12; 8; 12; 6; 8; 6; 8; 8 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Hormone Balance 8; 12; 12; 6; 12; 8; 12; 6; 8; 6; 8; 8 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Product Information

Package

Package Images

NDC 62185-0018-01 (62185001801)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2e77e321-a263-4918-ae40-7ca883deabbf Details

ACTIVE INGREDIENTS:

HOMEOPATHIC INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

HOMEOPATHIC INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

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