Burn Aide

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


Energique, Inc.
Human Otc Drug
NDC 44911-0662
Burn Aide also known as Calendula Officinalis, Hypericum Perforatum, Arsenicum Album, Belladonna, Cantharis, Causticum, Kali Bichromicum, Picricum Acidum, Urtica Urens is a human otc drug labeled by 'Energique, Inc.'. National Drug Code (NDC) number for Burn Aide is 44911-0662. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Burn Aide drug includes Arsenic Trioxide - 12 [hp_X]/mL Atropa Belladonna - 12 [hp_X]/mL Calendula Officinalis Flowering Top - 1 [hp_X]/mL Causticum - 12 [hp_X]/mL Hypericum Perforatum Whole - 1 [hp_X]/mL Lytta Vesicatoria - 12 [hp_X]/mL Picric Acid - 12 [hp_X]/mL Potassium Dichromate - 12 [hp_X]/mL Urtica Urens Whole - 12 [hp_X]/mL . The currest status of Burn Aide drug is Active.

Drug Information:

Drug NDC: 44911-0662
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Burn Aide
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Calendula Officinalis, Hypericum Perforatum, Arsenicum Album, Belladonna, Cantharis, Causticum, Kali Bichromicum, Picricum Acidum, Urtica Urens
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Energique, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Spray
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ARSENIC TRIOXIDE - 12 [hp_X]/mL
ATROPA BELLADONNA - 12 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP - 1 [hp_X]/mL
CAUSTICUM - 12 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE - 1 [hp_X]/mL
LYTTA VESICATORIA - 12 [hp_X]/mL
PICRIC ACID - 12 [hp_X]/mL
POTASSIUM DICHROMATE - 12 [hp_X]/mL
URTICA URENS WHOLE - 12 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 18 Nov, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 24 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Energique, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0363113701784
UPC stands for Universal Product Code.
UNII:S7V92P67HO
WQZ3G9PF0H
18E7415PXQ
DD5FO1WKFU
XK4IUX8MNB
3Q034RO3BT
A49OS0F91S
T4423S18FM
IHN2NQ5OF9
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
44911-0662-1180 mL in 1 BOTTLE, SPRAY (44911-0662-1)18 Nov, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose: may temporarily relieve itching, pain, and swelling associated with minor burns.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

Burn aide calendula officinalis, hypericum perforatum, arsenicum album, belladonna, cantharis, causticum, kali bichromicum, picricum acidum, urtica urens calendula officinalis flowering top calendula officinalis flowering top hypericum perforatum whole hypericum perforatum arsenic trioxide arsenic cation (3+) atropa belladonna atropa belladonna lytta vesicatoria lytta vesicatoria causticum causticum potassium dichromate dichromate ion picric acid picric acid urtica urens whole urtica urens glycerin water aloe vera leaf benzyl alcohol ethylhexylglycerin tocopherol carbomer copolymer type a (allyl pentaerythritol crosslinked) edetate disodium anhydrous sodium hydroxide alcohol

Indications and Usage:

Uses: may temporarily relieve itching, pain, and swelling associated with minor burns.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Warnings:

Warnings: for external use only. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, 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.

Dosage and Administration:

Directions: spray on affected area as needed. shake well before using.

Package Label Principal Display Panel:

Package label display: energique since 1987 homeopathic remedy burn aide spray 6 fl. oz. (180 ml) burn aide spray

Further Questions:

Questions: dist. by energique, inc. 201 apple blvd woodbine, ia 51579 800-869-8078


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.