NDC 61096-1039 Body Balance

Aralia Quin, Arnica, Avena, Carduus Mar, Elaeis, Glandula Suprarenalis Suis, Nat Mur, Phosphoricum Ac, Thuja Occ

NDC Product Code 61096-1039

NDC Code: 61096-1039

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: Aralia Quin, Arnica, Avena, Carduus Mar, Elaeis, Glandula Suprarenalis Suis, Nat Mur, Phosphoricum Ac, Thuja Occ 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

  • 61096 - Eight And Company L.l.c
    • 61096-1039 - Body Balance

NDC 61096-1039-1

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 41 mL in 1 BOTTLE, SPRAY

NDC Product Information

Body Balance with NDC 61096-1039 is a a human over the counter drug product labeled by Eight And Company L.l.c. The generic name of Body Balance is aralia quin, arnica, avena, carduus mar, elaeis, glandula suprarenalis suis, nat mur, phosphoricum ac, thuja occ. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Eight And Company L.l.c

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.

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.

  • AMERICAN GINSENG 4 [hp_X]/41mL
  • ARNICA MONTANA 4 [hp_X]/41mL
  • AVENA SATIVA FLOWERING TOP 4 [hp_X]/41mL
  • MILK THISTLE 4 [hp_X]/41mL
  • ELAEIS GUINEENSIS FRUIT 15 [hp_X]/41mL
  • SUS SCROFA ADRENAL GLAND 12 [hp_X]/41mL
  • SODIUM CHLORIDE 30 [hp_C]/41mL
  • PHOSPHORIC ACID 200 [hp_C]/41mL
  • THUJA OCCIDENTALIS LEAFY TWIG 200 [hp_C]/41mL

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: Eight And Company L.l.c
Labeler Code: 61096
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: 02-28-2019 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.

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

Otc - Active Ingredient

Active Ingredients: Aralia quinquefolia 3X, Arnica montana 3X, Carduus marianus 3X, Elaeis guineensis 10X, Glandula suprarenalis suis 12X, Natrum muriaticum 30C, Phosphoricum acidum 200C, Thuja occidentalis 200C

Warnings

Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

  • Directions:For adults only. 2 sprays into the mouth 3 times per day.

Otc - Purpose

  • Our adrenal glands can become exhausted from chronic stress, worry, overwork or poor nutrition. Temporarily relieves signs of adrenal exhaustion, including:dizziness, fatigue & weaknessmental stressloss of our sense of well being

Other Safety Information

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredient

Inactive Ingredients: Glycerin 10% v/v, non-GMO organic alcohol 9% v/v and purified water.

Indications & Usage

Our adrenal glands can become exhausted from chronic stress, worry, overwork or poor nutrition. Temporarily relieves signs of adrenal exhaustion, including:° dizziness fatigue & weakness° mental stress° loss of our sense of well being° natural° gluten free° no artificial flavors or colors° no known negative side effects° no known negative drug interactions

* Please review the disclaimer below.

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