NDC 44911-0635 Body Balance

Avena Sativa, Chlorophytum Borivilianum, Nuphar Luteum, Hypothalamus Suis, Orchitinum (suis), Damiana, Selenium Metallicum, Staphysagria, Thuja Occidentalis

NDC Product Code 44911-0635

NDC CODE: 44911-0635

Proprietary Name: Body 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, Chlorophytum Borivilianum, Nuphar Luteum, Hypothalamus Suis, Orchitinum (suis), Damiana, Selenium Metallicum, Staphysagria, Thuja Occidentalis 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

  • 44911 - Energique, Inc.

NDC 44911-0635-1

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC Product Information

Body Balance with NDC 44911-0635 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Body Balance is avena sativa, chlorophytum borivilianum, nuphar luteum, hypothalamus suis, orchitinum (suis), damiana, selenium metallicum, staphysagria, thuja occidentalis. The product's dosage form is spray and is administered via oral form.

Labeler Name: Energique, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Body 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 3 [hp_X]/mL
  • CHLOROPHYTUM BORIVILIANUM WHOLE 3 [hp_X]/mL
  • PUNICA GRANATUM ROOT BARK 6 [hp_X]/mL
  • NUPHAR LUTEA ROOT 6 [hp_X]/mL
  • BOS TAURUS HYPOTHALAMUS 6 [hp_X]/mL
  • SUS SCROFA TESTICLE 6 [hp_X]/mL
  • TURNERA DIFFUSA LEAFY TWIG 9 [hp_X]/mL
  • SELENIUM 9 [hp_X]/mL
  • DELPHINIUM STAPHISAGRIA SEED 9 [hp_X]/mL
  • THUJA OCCIDENTALIS LEAFY TWIG 12 [hp_X]/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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • 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: 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: 03-16-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Body Balance Product Label Images

Body 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:

(in each spray): 6.64% of Damiana 9X, Granatum 6X, Hypothalamus Suis 6X, 12X, 30X, 12C, 30C, Nuphar Luteum 6X, Orchitinum (Suis) 6X, 12X, 30X, 12C, 30C, Staphysagria 9X, Thuja Occidentalis 12X;0.10% of Avena Sativa 3X, Chlorophytum Borivilianum 3X, Selenium Metallicum 9X.

Indications:

Temporarily relieves symptoms of low sexual energy and dysfunction which may be due to prostatitis, endometritis, endometriosis, low or poor sperm production, fatigue and decreased responsiveness.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Temporarily relieves symptoms of low sexual energy and dysfunction which may be due to prostatitis, endometritis, endometriosis, low or poor sperm production, fatigue and decreased responsiveness.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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:

Adults only. Spray 2 times under the tongue 2 times a day. If symptoms persist, consult your health care professional.

Inactive Ingredients:

Citric acid, Demineralized water, 25% Ethanol.

Questions:

Dist. by Energique, Inc.201 Apple Blvd.Woodbine, IA 51579 800.869.8078

Package Display Label:

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

* Please review the disclaimer below.