NDC 43857-0400 Injury Topical

Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Carbo Vegetabilis, Hamamelis Virginiana, Millefolium, Rhus Tox, Ruta Graveolens, Veratrum Album

NDC Product Information

Injury Topical with NDC 43857-0400 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Injury Topical is calendula officinalis, arnica montana, hypericum perforatum, symphytum officinale, bellis perennis, carbo vegetabilis, hamamelis virginiana, millefolium, rhus tox, ruta graveolens, veratrum album. The product's dosage form is gel and is administered via topical form.

Labeler Name: Bioactive Nutritional, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Injury Topical 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.

  • CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g
  • ARNICA MONTANA 1 [hp_X]/g
  • HYPERICUM PERFORATUM 3 [hp_X]/g
  • COMFREY ROOT 6 [hp_X]/g
  • BELLIS PERENNIS 12 [hp_X]/g
  • ACTIVATED CHARCOAL 12 [hp_X]/g
  • HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 12 [hp_X]/g
  • ACHILLEA MILLEFOLIUM 12 [hp_X]/g
  • TOXICODENDRON PUBESCENS LEAF 12 [hp_X]/g
  • RUTA GRAVEOLENS FLOWERING TOP 12 [hp_X]/g
  • VERATRUM ALBUM ROOT 12 [hp_X]/g

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

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: 09-01-2016 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.

Injury Topical Product Label Images

Injury Topical 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:

Calendula Officinalis MT, Arnica Montana MT, 3X, Hypericum Perforatum 3X, 12X, Symphytum Officinale 6X, Bellis Perennis 12X, Carbo Vegetabilis 12X, Hamamelis Virginiana 12X, Millefolium 12X, Rhus Tox 12X, Ruta Graveolens 12X, Veratrum Album 12X.

Indications:

For bumps, bruises, abrasions, strains, sprains, fractures, stiffness.  For all body and head injuries.

For bumps, bruises, abrasions, strains, sprains, fractures, stiffness. For all body and head injuries.

Warnings:

For External Use OnlyIf 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:

Apply small amount every 10 minutes for 3 doses immediately after injury, then 2-3 times daily.

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethanol

Questions:

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

Package Label Display:

BIOActive NutritionalINJURY TOPICALHOMEOPATHICNET WT 2 OZ (56.7 g)

* Please review the disclaimer below.