NDC 62185-0050 Hormone Balance

Acetaldehyde, Dopamine Hydrochloride, Dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone-3b-acetate, Folliculinum, Oophorinum (suis), Cholesterinum, Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone

NDC Product Code 62185-0050

NDC Code: 62185-0050

Proprietary Name: Hormone Balance What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaldehyde, Dopamine Hydrochloride, Dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone-3b-acetate, Folliculinum, Oophorinum (suis), Cholesterinum, Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 62185 - Dr. Donna Restivo Dc

NDC 62185-0050-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Hormone Balance with NDC 62185-0050 is a a human over the counter drug product labeled by Dr. Donna Restivo Dc. The generic name of Hormone Balance is acetaldehyde, dopamine hydrochloride, dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone-3b-acetate, folliculinum, oophorinum (suis), cholesterinum, progesterone, testosterone, cortisone aceticum, aldosterone, androsterone, follicle stimulating hormone. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Dr. Donna Restivo Dc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

DEA Schedule: Schedule III (CIII) Substances What is the Drug Enforcement Administration (DEA) CIII Schedule?
The controlled substances in the CIII schedule have an abuse potential and dependence liability less than those in schedules CI and CII, and have an accepted medical use in the United States. Schedule CIII controlled substances include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine.

Hormone Balance Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETALDEHYDE 6 [hp_X]/mL
  • DOPAMINE HYDROCHLORIDE 6 [hp_X]/mL
  • 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE 6 [hp_X]/mL
  • ESTRONE 8 [hp_X]/mL
  • SUS SCROFA OVARY 8 [hp_X]/mL
  • CHOLESTEROL 8 [hp_X]/mL
  • PROGESTERONE 8 [hp_X]/mL
  • TESTOSTERONE 8 [hp_X]/mL
  • CORTISONE ACETATE 12 [hp_X]/mL
  • ALDOSTERONE 12 [hp_C]/mL
  • ANDROSTERONE 12 [hp_C]/mL
  • FOLLITROPIN 12 [hp_C]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dr. Donna Restivo Dc
Labeler Code: 62185
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-03-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hormone Balance Product Label Images

Hormone Balance Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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.

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:

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.

Inactive Ingredients:

Demineralized water, 25% ethanol.

Questions:

Distributed by Dr. Donna Restivo DC, Wellness Consultant822 South Lake Blvd, Mahopac, New York 10541www.mahopacmassage.com • (845) 628-6286

Package Label Display:

DR. DONNA RESTIVO DCWELLNESS CONSULTANTNDC 62185-0041-1HOMEOPATHICHormone Balance1 FL OZ (30 ml)

* Please review the disclaimer below.