NDC 43857-0537 Household Antigens

Acetone, Sodium Tripolyphosphate, Propylene Glycol, Benzinum, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Anacardium Orientale, Graphites, Nitricum Acidum, Pulsatilla (pratensis), Sulphur

NDC Product Code 43857-0537

NDC CODE: 43857-0537

Proprietary Name: Household Antigens 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: Acetone, Sodium Tripolyphosphate, Propylene Glycol, Benzinum, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Anacardium Orientale, Graphites, Nitricum Acidum, Pulsatilla (pratensis), Sulphur 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

NDC 43857-0537-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Household Antigens with NDC 43857-0537 is a a human over the counter drug product labeled by Bioactive Nutritional. The generic name of Household Antigens is acetone, sodium tripolyphosphate, propylene glycol, benzinum, ammonium muriaticum, sodium lauryl sulfate, terebinthina, anacardium orientale, graphites, nitricum acidum, pulsatilla (pratensis), sulphur. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional

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.

Household Antigens 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.

  • ACETONE 9 [hp_X]/mL
  • SODIUM TRIPOLYPHOSPHATE 9 [hp_X]/mL
  • PROPYLENE GLYCOL 9 [hp_X]/mL
  • BENZENE 9 [hp_X]/mL
  • AMMONIUM CHLORIDE 9 [hp_X]/mL
  • SODIUM LAURYL SULFATE 9 [hp_X]/mL
  • TURPENTINE OIL 9 [hp_X]/mL
  • SEMECARPUS ANACARDIUM JUICE 12 [hp_X]/mL
  • GRAPHITE 12 [hp_X]/mL
  • NITRIC ACID 12 [hp_X]/mL
  • ANEMONE PRATENSIS 12 [hp_X]/mL
  • SULFUR 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
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: 10-08-2019 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.

Household Antigens Product Label Images

Household Antigens 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:

Acetonum Acetone 9X, 12X, 15X,30X, Sodium Tripolyphosphate 9X, 12X, 15X, 30X, Propylene Glycol 9X, 12X, 15X, 30X, Benzinum 9X, 12X, 15X, 30X, Ammonium Muriaticum 9X, 12X, 15X, 30X, Sodium Lauryl Sulfate 9X, 12X, 15X, 30X, Terebinthina 9X, 12X, 15X, 30X, Anacardium Orientale 12X , Graphites 12X, Nitricum Acidum 12X, Pulsatilla (Pratensis) 12X, Sulphur 12X.

For the temporary relief of allergies due to household products.

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 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:

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

Indications:

For the temporary relief of allergies due to household products.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com*For a complete list of Environmental Isode Contact BioActive Nutritional, Inc.

Package Display Label:

BIOActive NutritionalHOUSEHOLD ANTIGENSHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.