NDC 44911-0126 Male Balance

Avena Sativa, Hepar Suis, Orchitinum (suis), Testosterone, Agnus Castus, Damiana, Ginkgo Biloba, Hypothalamus (suis), Lycopodium Clabatum, Spermidine, Spermine, Human Growth Hormone, Epimedium Grandiflorum, Serotonin (hydrochloride)

NDC Product Code 44911-0126

NDC CODE: 44911-0126

Proprietary Name: Male 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: Avena Sativa, Hepar Suis, Orchitinum (suis), Testosterone, Agnus Castus, Damiana, Ginkgo Biloba, Hypothalamus (suis), Lycopodium Clabatum, Spermidine, Spermine, Human Growth Hormone, Epimedium Grandiflorum, Serotonin (hydrochloride) 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medicated patch contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (e.g., hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels. Testosterone helps the body to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire. This drug should not be used by women.
  • Various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting. Somatropin is also used to increase height in children with certain disorders (such as Noonan syndrome, Turner syndrome, idiopathic short stature).

NDC Code Structure

  • 44911 - Energique,inc.

NDC 44911-0126-1

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC Product Information

Male Balance with NDC 44911-0126 is a a human over the counter drug product labeled by Energique,inc.. The generic name of Male Balance is avena sativa, hepar suis, orchitinum (suis), testosterone, agnus castus, damiana, ginkgo biloba, hypothalamus (suis), lycopodium clabatum, spermidine, spermine, human growth hormone, epimedium grandiflorum, serotonin (hydrochloride). The product's dosage form is liquid and is administered via oral form.

Labeler Name: Energique,inc.

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.

Male 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.

  • AVENA SATIVA FLOWERING TOP 6 [hp_X]/mL
  • PORK LIVER 6 [hp_X]/mL
  • SUS SCROFA TESTICLE 6 [hp_X]/mL
  • TESTOSTERONE 6 [hp_X]/mL
  • CHASTE TREE 12 [hp_X]/mL
  • TURNERA DIFFUSA LEAFY TWIG 12 [hp_X]/mL
  • GINKGO 12 [hp_X]/mL
  • SUS SCROFA HYPOTHALAMUS 12 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL
  • SPERMIDINE 12 [hp_X]/mL
  • SPERMINE 12 [hp_X]/mL
  • SOMATROPIN 26 [hp_X]/mL
  • EPIMEDIUM GRANDIFLORUM TOP 30 [hp_C]/mL
  • SEROTONIN HYDROCHLORIDE 30 [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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • WATER (UNII: 059QF0KO0R)

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.
  • 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: Energique,inc.
Labeler Code: 44911
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: 09-15-2014 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.

Male Balance Product Label Images

Male 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

Avena Sativa 6X, Hepar Suis 6X, Orchitinum (Suis) 6X, Testosterone 6X, Agnus Castus 12X, Damiana 12X, Ginkgo Biloba 12X, Hypothalamus (Suis) 12X, Lycopodium Clabatum 12X, Spermidine 12X, 30X, Spermine 12X, 30X, Human Growth Hormone 26X, Epimedium Grandiflorum 30C, Serotonin (Hydrochloride) 30C

Indications:

For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Two sprays twice daily. Hold in mouth for 30 seconds.

Inactive Ingredients:

Citric Acid, Demineralized Water, Glycerin, Sodium Benzoate.

Questions:

Dist. by Energique, Inc.201 Apple BlvdWoodbine, IA 51579  800-869-8078

Package Label Display

ENERGIQUESINCE 1987HOMEOPATHIC REMEDYMALE BALANCE1 fl. oz. (30 ml)

* Please review the disclaimer below.