FDA.reportPublic FDA data

Burn Aide

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-08-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:27:43

Label at a glance#

ProductBurn Aide
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM WHOLE, ARSENIC TRIOXIDE, ATROPA BELLADONNA, LYTTA VESICATORIA, CAUSTICUM, POTASSIUM DICHROMATE, PICRIC ACID, URTICA URENS WHOLE
Label structure9 sections

Indications and 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.

Dosage and administration

Spray on affected area as needed. Shake well before using.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 8.31% of Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Hypericum Perforatum 30X, Kali Bichromicum 12X, Picricum Acidum 12X, Urtica Urens 12X; 1.75% of Calendula Officinalis 1X, Hypericum Perforatum 1X.

PURPOSE:

OTC - PURPOSE SECTION

May temporarily relieve itching, pain, and swelling associated with minor burns.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

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 SECTION

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.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Spray on affected area as needed. Shake well before using.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water, Ethanol, Glycerin, Aloe vers leaf juice extract, Benzyl alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 alkyl acrylate crosspolymer, Disodium EDTA, Sodium hydroxide. 

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

BURN AIDE

SPRAY

6 fl. OZ. (180 ml)

Burn Aide SprayBurn Aide Spray

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0662-12024-08-05C16284748780-11030e365-60b1-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0662-12024-01-30C16284748780-11030e365-60b1-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0662-1Burn Aide180 mL in 1 BOTTLE, SPRAYSPRAY1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0662BURN AIDE (CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, ARSENICUM ALBUM, BELLADONNA, CANTHARIS, CAUSTICUM, KALI BICHROMICUM, PICRICUM ACIDUM, URTICA URENS) SPRAY [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20240806_62ce13b1-ca8d-4d6b-932d-db13a816bc37.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-066244911-0662-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CAUSTICUMDD5FO1WKFUACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
PICRIC ACIDA49OS0F91SACTIB
URTICA URENS WHOLEIHN2NQ5OF9ACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn AideCALENDULA OFFICINALIS, HYPERICUM PERFORATUM, ARSENICUM ALBUM, BELLADONNA, CANTHARIS, CAUSTICUM, KALI BICHROMICUM, PICRICUM ACIDUM, URTICA URENSEnergique, Inc.62ce13b1-ca8d-4d6b-932d-db13a816bc372024-08-05WarningsExact identifier
ndc (package): 44911-0662-1
ndc (product): 44911-0662
ndc11 (package): 44911066201
spl id: a3fb5283-fe75-46e1-bb7a-d29e7b78ec97
spl set id: 62ce13b1-ca8d-4d6b-932d-db13a816bc37

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.