NDC 43857-0472 Burn Aide

Calendula Officinalis, Hypericum Perforatum, Arsenicum Album, Belladonna, Cantharis, Causticum, Picricum Acidum, Urtica Urens

NDC Product Information

Burn Aide with NDC 43857-0472 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Burn Aide is calendula officinalis, hypericum perforatum, arsenicum album, belladonna, cantharis, causticum, picricum acidum, urtica urens. The product's dosage form is spray and is administered via topical form.

Labeler Name: Bioactive Nutritional, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Burn Aide 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]/mL
  • HYPERICUM PERFORATUM 1 [hp_X]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • ATROPA BELLADONNA 12 [hp_X]/mL
  • LYTTA VESICATORIA 12 [hp_X]/mL
  • CAUSTICUM 12 [hp_X]/mL
  • PICRIC ACID 12 [hp_X]/mL
  • URTICA URENS 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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • 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.

  • 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: 03-13-2018 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.

Burn Aide Product Label Images

Burn Aide 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, Hypericum Perforatum MT, 30X, Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Picricum Acidum 12X, Urtica Urens 12X.

Indications:

For temporary relief of minor burns.

For temporary relief of minor burns.

Warnings:

For external use only.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.Do not get in your eyes. If you get Burn Aide in your eyes, rinse immediately with cool tap water. In case of serious burns, consult a doctor. If your symptoms do not get better in seven days or if they get worse, check with your doctor.

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:

Clean the affected area. Spray on affected area as needed.

Inactive Ingredients:

Demineralized Water, Aloe Vera Thickened Gel (Aloe Barbadensis Leaf Juice, Water, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA Sodium Hydroxide), 10.7% Ethanol.

Questions:

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

Package Label Display:

BIOActive NutritionalBURN AIDEHOMEOPATHIC4 FL OZ (120 ml)

* Please review the disclaimer below.