NDC 43857-0405 Pneumotox

Triticum Aestivum, Alfalfa, Arnica Montana, Asclepias Tuberosa, Chamomilla, Echinacea (angustifolia), Eucalyptus Globulus, Fucus Vesiculosus, Hordeum Vulgare, Laminaria Digitata, Nasturtium Aquaticum, Plantago Major, Raphanus Sativus, Trifolium Pratense, Trigonella Foenum-graecum, Symphytum Officinale, Lung (suis), Oryza Sativa, Silicea, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Arsenicum Album

NDC Product Code 43857-0405

NDC CODE: 43857-0405

Proprietary Name: Pneumotox 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: Triticum Aestivum, Alfalfa, Arnica Montana, Asclepias Tuberosa, Chamomilla, Echinacea (angustifolia), Eucalyptus Globulus, Fucus Vesiculosus, Hordeum Vulgare, Laminaria Digitata, Nasturtium Aquaticum, Plantago Major, Raphanus Sativus, Trifolium Pratense, Trigonella Foenum-graecum, Symphytum Officinale, Lung (suis), Oryza Sativa, Silicea, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Arsenicum Album 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.

  • Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).
  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.
  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0405-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Pneumotox with NDC 43857-0405 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Pneumotox is triticum aestivum, alfalfa, arnica montana, asclepias tuberosa, chamomilla, echinacea (angustifolia), eucalyptus globulus, fucus vesiculosus, hordeum vulgare, laminaria digitata, nasturtium aquaticum, plantago major, raphanus sativus, trifolium pratense, trigonella foenum-graecum, symphytum officinale, lung (suis), oryza sativa, silicea, acetone, sodium tripolyphosphate, propylene glycol, sodium benzene sulfonate, ammonium muriaticum, sodium lauryl sulfate, terebinthina, arsenicum album. 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.

Pneumotox 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.

  • TRITICUM AESTIVUM WHOLE 1 [hp_X]/mL
  • ALFALFA 3 [hp_X]/mL
  • ARNICA MONTANA 3 [hp_X]/mL
  • ASCLEPIAS TUBEROSA ROOT 3 [hp_X]/mL
  • MATRICARIA RECUTITA 3 [hp_X]/mL
  • ECHINACEA ANGUSTIFOLIA 3 [hp_X]/mL
  • EUCALYPTUS GLOBULUS LEAF 3 [hp_X]/mL
  • FUCUS VESICULOSUS 3 [hp_X]/mL
  • HORDEUM VULGARE TOP 3 [hp_X]/mL
  • LAMINARIA DIGITATA 3 [hp_X]/mL
  • NASTURTIUM OFFICINALE 3 [hp_X]/mL
  • PLANTAGO MAJOR 3 [hp_X]/mL
  • RAPHANUS SATIVUS 3 [hp_X]/mL
  • TRIFOLIUM PRATENSE FLOWER 3 [hp_X]/mL
  • TRIGONELLA FOENUM-GRAECUM WHOLE 3 [hp_X]/mL
  • SYMPHYTUM OFFICINALE WHOLE 6 [hp_X]/mL
  • SUS SCROFA LUNG 8 [hp_X]/mL
  • ORYZA SATIVA WHOLE 8 [hp_X]/mL
  • SILICON DIOXIDE 8 [hp_X]/mL
  • ACETONE 9 [hp_X]/mL
  • SODIUM TRIPOLYPHOSPHATE 9 [hp_X]/mL
  • PROPYLENE GLYCOL 9 [hp_X]/mL
  • SODIUM BENZENESULFONATE 9 [hp_X]/mL
  • AMMONIUM CHLORIDE 9 [hp_X]/mL
  • SODIUM LAURYL SULFATE 9 [hp_X]/mL
  • TURPENTINE OIL 9 [hp_X]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • SODIUM CHLORIDE 12 [hp_X]/mL
  • NITRIC ACID 12 [hp_X]/mL
  • OENANTHE AQUATICA FRUIT 12 [hp_X]/mL
  • PHOSPHORIC ACID 12 [hp_X]/mL
  • PHOSPHORUS 12 [hp_X]/mL
  • PULSATILLA VULGARIS 12 [hp_X]/mL
  • TOXICODENDRON PUBESCENS LEAF 12 [hp_X]/mL
  • PARAFFIN 30 [hp_X]/mL
  • ETHYLENE GLYCOL 30 [hp_X]/mL
  • PROPYL ALCOHOL 30 [hp_X]/mL
  • PALMITIC ACID 30 [hp_X]/mL
  • DIMETHICONE 30 [hp_X]/mL
  • POLYACRYLIC ACID (8000 MW) 30 1/mL
  • GLUTARAL 30 [hp_X]/mL
  • METHYL METHACRYLATE 30 [hp_X]/mL
  • ANHYDROUS CITRIC ACID 30 [hp_X]/mL
  • TARTARIC ACID 30 [hp_X]/mL
  • ANTHRAQUINONE 30 [hp_X]/mL
  • HYDROGEN PEROXIDE 30 [hp_X]/mL
  • GLYCOLIC ACID 30 [hp_X]/mL
  • AMMONIUM THIOGLYCOLATE 30 [hp_X]/mL
  • SODIUM CARBONATE 30 [hp_X]/mL
  • MONOETHANOLAMINE 30 [hp_X]/mL
  • TOLUENE-2,5-DIAMINE 30 [hp_X]/mL
  • P-AMINOPHENOL 30 [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: 08-03-2016 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.

Pneumotox Product Label Images

Pneumotox 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:

Triticum Aestivum 3X, Alfalfa 3X, Arnica Montana 3X, Asclepias Tuberosa 3X, Chamomilla 3X, Echinacea (Angustifolia) 3X, Eucalyptus Globulus 3X, Fucus Vesiculosus 3X, Hordeum Vulgare 3X, Laminaria Digitata 3X, Nasturtium Aquaticum 3X, Plantago Major 3X, Raphanus Sativus 3X, Trifolium Pratense 3X, Trigonella Foenum-Graecum 3C, Symphytum Officinale 6X, Lung (Suis) 8X, Oryza Sativa 8X, Silicea 8X, Acetone 9X, 12X, 15X, 30X, Sodium Tripolyphosphate 9X, 12X, 15X, 30X, Propylene Glycol 9X, 12X, 15X, 30X, Sodium Benzene Sulfonate 9X, 12X, 15X, 30X, Ammonium Muriaticum 9X, 12X, 15X, 30X, Sodium Lauryl Sulfate 9X, 12X, 15X, 30X, Terebinthina 9X, 12X, 15X, 30X, Arsenicum Album 12X, Natrum Muriaticum 12X, Nitricum Acidum 12X, Phellandrium Aquaticum 12X, Phosphoricum Acidum 12X, Phosphorus, Pulsatilla (Vulgaris) 12X, Rhus Tox 12X, Paraffinum 30X, 60X, 200X, Ethylene Glycol 30X, 60X, 200X, Propanol 30X, 60X, 200X, Hexadecanoic Acid 30X, 60X, 200X, Dimethicone 30X, 60X, 200X, Poly Acrylic Acid 30X, 60X, 200X, Glutaraldehyde 30X, 60X, 200X, Methacrylates 30X, 60X, 200X, Citricum Acidum 30X, 60X, 200X, Tartaricum Acidum 30X, 60X, 200X, Anthrachinonum 30X, 60X, 200X, Hydrogen Peroxide 30X, 60X, 200X, Glycolic Acid 30X, 60X, 200X, Ammonium Thioglycolate 30X, 60X, 200X, Natrum Carbonicum 30X, 60X, 200X, Ethanolamine 30X, 60X, 200X, 2,5 Diaminotoluene (Sulfate) 30X, 60X, 200X, 4 Amino Phenol 30X, 60X, 200XContains Wheat

Indications:

For temporary relief of cough, pressure upon the chest, and cough with expectoration as a consequence of exposure to pollutants.

For temporary relief of cough, pressure upon the chest, and cough with expectoration as a consequence of exposure to pollutants.

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*For a complete list of Universal Toxins Isodes and Environmental Isodes contact BioActive Nutritional, Inc.

Package Label Display:

BIOActive NutritionalPNEUMOTOXHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.