FDA.reportPublic FDA data

Burn Aide

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:28:20

Label at a glance#

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

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of minor burns.

WARNINGS:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of minor burns.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

BURN AIDE

HOMEOPATHIC

4 FL OZ (120 ml)

Burn AideBurn Aide

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
43857-0472-12024-10-22C16284748780-1ba0f9c33-1e7a-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0472-12021-01-29C16284748780-1ba0f9c33-1e7a-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0472-1Burn Aide120 mL in 1 BOTTLE, SPRAYSPRAY1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0472BURN AIDE (CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, ARSENICUM ALBUM, BELLADONNA, CANTHARIS, CAUSTICUM, PICRICUM ACIDUM, URTICA URENS) SPRAY [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20241024_66f41f76-7c1f-4bd4-a6f1-cba9647c4f5c.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-047243857-0472-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CAUSTICUMDD5FO1WKFUACTIB
PICRIC ACIDA49OS0F91SACTIB
URTICA URENS WHOLEIHN2NQ5OF9ACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
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, PICRICUM ACIDUM, URTICA URENSBioActive Nutritional, Inc.66f41f76-7c1f-4bd4-a6f1-cba9647c4f5c2024-10-22WarningsExact identifier
ndc (package): 43857-0472-1
ndc (product): 43857-0472
ndc11 (package): 43857047201
spl id: f24eeb11-c61d-41d2-bb03-e55ed99fe554
spl set id: 66f41f76-7c1f-4bd4-a6f1-cba9647c4f5c

Reported adverse events (FAERS/openFDA)#

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