NDC 43857-0295 Ear

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

NDC Product Code 43857-0295

NDC CODE: 43857-0295

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), Hydrastis Canadensis, Phytolacca Decandra, 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.

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 medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with water pills/diuretics.

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0295-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Ear with NDC 43857-0295 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Ear is baptisia tinctoria, echinacea (angustifolia), hydrastis canadensis, phytolacca decandra, capsicum annuum, chamomilla, ferrum phosphoricum, kali muriaticum, plantago major, pulsatilla (vulgaris). The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, 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.

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.

  • BAPTISIA TINCTORIA ROOT 3 [hp_X]/mL
  • ECHINACEA ANGUSTIFOLIA 3 [hp_X]/mL
  • GOLDENSEAL 3 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 3 [hp_X]/mL
  • CAPSICUM 12 [hp_X]/mL
  • MATRICARIA RECUTITA 12 [hp_X]/mL
  • FERROSOFERRIC PHOSPHATE 12 [hp_X]/mL
  • POTASSIUM CHLORIDE 12 [hp_X]/mL
  • PLANTAGO MAJOR 12 [hp_X]/mL
  • PULSATILLA VULGARIS 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.

  • 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.
  • 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: 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: 08-18-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 05-05-2021 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 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.

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, Hydrastis Canadensis 3X, Phytolacca Decandra 3X, 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 NUTRITIONALMelbourne, FL 32935For Nutritional Information write:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935

Package Label Display:

BIOActive NutritionalEARHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.