NDC 43857-0473 Ear

Baptisia Tinctoria, Echinacea (angustifolia), Phytolacca Decandra, Hydrastis Canadensis, Capsicum Annuum, Chamomilla, Ferrum Phosphoricum, Kali Muriaticum, Plantago Major, Pulsatilla (vulgaris)

NDC Product Code 43857-0473

NDC CODE: 43857-0473

Proprietary Name: Ear 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: Baptisia Tinctoria, Echinacea (angustifolia), Phytolacca Decandra, Hydrastis Canadensis, Capsicum Annuum, Chamomilla, Ferrum Phosphoricum, Kali Muriaticum, Plantago Major, Pulsatilla (vulgaris) 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

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0473-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Ear with NDC 43857-0473 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Ear is baptisia tinctoria, echinacea (angustifolia), phytolacca decandra, hydrastis canadensis, capsicum annuum, chamomilla, ferrum phosphoricum, kali muriaticum, plantago major, pulsatilla (vulgaris). The product's dosage form is liquid and is administered via oral form.

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.

Ear 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.


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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Dietary Proteins - [CS]
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Plant Proteins - [CS]
  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Vegetable Proteins - [CS]

Product Labeler Information

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

Labeler Name: Bioactive Nutritional, Inc.
Labeler Code: 43857
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: 03-22-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 02-25-2024 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Ear Product Label Images

Ear 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:

Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Phytolacca Decandra 3X, Hydrastis Canadensis 5X, Capsicum Annuum 12X, Chamomilla 12X, Ferrum Phosphoricum 12X, Kali Muriaticum 12X, Plantago Major 12X, Pulsatilla (Vulgaris) 12X.

Indications:

For temporary relief of mild earache with soreness, sticking pain in ears, and minor swelling of the ear with redness.

For temporary relief of mild earache with soreness, sticking pain in ears, and minor swelling of the ear with redness.

Warnings:

If pregnant or breast-feeding, ask a health care 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 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:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com

Package Label Display:

BIOActive NutritionalEARHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.