NDC 43857-0530 Bac

Echinacea (angustifolia), Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Hydrastis Canadensis, Propolis, Glandula Suprarenalis Suis, Lymph Node (suis), Spleen (suis), Thymus (suis), Thyroidinum (suis), Arsenicum Album, Belladonna, Hypericum Perforatum, Phosphorus, Botulinum, Escherichia Coli, Proteus (vulgaris), Pseudomonas Aeruginosa, Proteus (morgani), Salmonella Typhi Nosode, Clostridium Perfringens

NDC Product Code 43857-0530

NDC CODE: 43857-0530

Proprietary Name: Bac 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: Echinacea (angustifolia), Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Hydrastis Canadensis, Propolis, Glandula Suprarenalis Suis, Lymph Node (suis), Spleen (suis), Thymus (suis), Thyroidinum (suis), Arsenicum Album, Belladonna, Hypericum Perforatum, Phosphorus, Botulinum, Escherichia Coli, Proteus (vulgaris), Pseudomonas Aeruginosa, Proteus (morgani), Salmonella Typhi Nosode, Clostridium Perfringens 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).

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0530-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Bac with NDC 43857-0530 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Bac is echinacea (angustifolia), lomatium dissectum, myrrha, nasturtium aquaticum, tabebuia impetiginosa, hydrastis canadensis, propolis, glandula suprarenalis suis, lymph node (suis), spleen (suis), thymus (suis), thyroidinum (suis), arsenicum album, belladonna, hypericum perforatum, phosphorus, botulinum, escherichia coli, proteus (vulgaris), pseudomonas aeruginosa, proteus (morgani), salmonella typhi nosode, clostridium perfringens. 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.

Bac 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.

  • ECHINACEA ANGUSTIFOLIA 3 [hp_X]/mL
  • LOMATIUM DISSECTUM ROOT 3 [hp_X]/mL
  • MYRRH 3 [hp_X]/mL
  • NASTURTIUM OFFICINALE 3 [hp_X]/mL
  • TABEBUIA IMPETIGINOSA BARK 3 [hp_X]/mL
  • GOLDENSEAL 5 [hp_X]/mL
  • PROPOLIS WAX 6 [hp_X]/mL
  • SUS SCROFA ADRENAL GLAND 8 [hp_X]/mL
  • SUS SCROFA LYMPH 8 [hp_X]/mL
  • SUS SCROFA SPLEEN 8 [hp_X]/mL
  • SUS SCROFA THYMUS 8 [hp_X]/mL
  • SUS SCROFA THYROID 8 [hp_X]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • ATROPA BELLADONNA 12 [hp_X]/mL
  • HYPERICUM PERFORATUM 12 [hp_X]/mL
  • PHOSPHORUS 12 [hp_X]/mL
  • BOTULINUM TOXIN TYPE A 30 [hp_X]/mL
  • ESCHERICHIA COLI 30 [hp_X]/mL
  • PROTEUS VULGARIS 30 [hp_X]/mL
  • PSEUDOMONAS AERUGINOSA 30 [hp_X]/mL
  • PROTEUS MORGANII 30 [hp_X]/mL
  • SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 33 [hp_X]/mL
  • CLOSTRIDIUM PERFRINGENS 15 [hp_C]/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: 12-26-2019 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.

Bac Product Label Images

Bac 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:

Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Myrrha 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Hydrastis Canadensis 5X, Propolis 6X, Glandula Suprarenalis Suis 8X, Lymph Node (Suis) 8X, Spleen (Suis) 8X, Thymus (Suis) 8X, Thyroidinum (Suis) 8X, Arsenicum Album 12X, Belladonna 12X, Hypericum Perforatum 12X, Phosphorus 12X, Botulinum 30X, 60X, Escherichia Coli 30X, 60X, Proteus (Vulgaris) 30X, 60X, Pseudomonas Aeruginosa 30X, 60X, Proteus (Morgani) 30X, 60X, Salmonella Typhi Nosode 33X, 60X, Clostridium Perfringens 15C, 30C.

Indications:

For temporary relief of fever, sore throat and acute irritation of the bladder.

For temporary relief of fever, sore throat and acute irritation of the bladder.

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.WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by physician.

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 NutritionalBACHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.